@prefix : <https://aking1997.github.io/medtech-safety-ontology/doc#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix xml: <http://www.w3.org/XML/1998/namespace> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@base <https://aking1997.github.io/medtech-safety-ontology/doc#> .

<https://aking1997.github.io/medtech-safety-ontology/doc> rdf:type owl:Ontology ;
                                                           <http://purl.org/dc/terms/created> "2026-04-27"^^xsd:date ;
                                                           <http://purl.org/dc/terms/creator> "aking1997" ;
                                                           <http://purl.org/dc/terms/license> <http://creativecommons.org/licenses/by/4.0/> ;
                                                           <http://purl.org/dc/terms/title> "MedTech Safety & Traceability Ontology (EUDAMED-MDR)"@en ;
                                                           rdfs:comment "Ontology for the MDR/IVDR regulatory framework representing Devices, Manufacturers, Incidents, Risks, and Corrective Actions."@en ;
                                                           owl:versionInfo "1.0" ;
                                                           <https://w3id.org/mod#createdWith> <https://chowlk.linkeddata.es/> .

#################################################################
#    Annotation properties
#################################################################

###  http://purl.org/dc/terms/created
<http://purl.org/dc/terms/created> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/creator
<http://purl.org/dc/terms/creator> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/license
<http://purl.org/dc/terms/license> rdf:type owl:AnnotationProperty .


###  http://purl.org/dc/terms/title
<http://purl.org/dc/terms/title> rdf:type owl:AnnotationProperty .


###  https://w3id.org/mod#createdWith
<https://w3id.org/mod#createdWith> rdf:type owl:AnnotationProperty .


#################################################################
#    Datatypes
#################################################################

###  http://www.w3.org/2001/XMLSchema#date
xsd:date rdf:type rdfs:Datatype .


#################################################################
#    Object Properties
#################################################################

###  https://aking1997.github.io/medtech-safety-ontology/doc#addressesIncident
:addressesIncident rdf:type owl:ObjectProperty ;
                   rdfs:domain :FSCA ;
                   rdfs:range :Incident ;
                   rdfs:comment "Connects a corrective action (FSCA) to the incident it addresses."@en ;
                   rdfs:label "addresses incident"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#affectsDeviceType
:affectsDeviceType rdf:type owl:ObjectProperty ;
                   rdfs:domain :Risk ;
                   rdfs:range :Device ;
                   rdfs:comment "Links a specific risk category to the types of devices it generally affects."@en ;
                   rdfs:label "affects device type"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#associatedWithRisk
:associatedWithRisk rdf:type owl:ObjectProperty ;
                    rdfs:domain :Incident ;
                    rdfs:range :Risk ;
                    rdfs:comment "Links an incident to the identified IMDRF risk category."@en ;
                    rdfs:label "associated with risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#hasManufacturer
:hasManufacturer rdf:type owl:ObjectProperty ;
                 rdfs:domain :Device ;
                 rdfs:range :Manufacturer ;
                 rdfs:comment "Links a medical device to its manufacturer."@en ;
                 rdfs:label "has manufacturer"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#involvesDevice
:involvesDevice rdf:type owl:ObjectProperty ;
                rdfs:domain :Incident ;
                rdfs:range :Device ;
                rdfs:comment "Indicates the medical device involved in a specific incident."@en ;
                rdfs:label "involves device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#manufacturesDevice
:manufacturesDevice rdf:type owl:ObjectProperty ;
                    rdfs:domain :Manufacturer ;
                    rdfs:range :Device ;
                    rdfs:comment "Links a manufacturer to the devices it produces (Inverse of hasManufacturer)."@en ;
                    rdfs:label "manufactures device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#reportedBy
:reportedBy rdf:type owl:ObjectProperty ;
            rdfs:domain :Incident ;
            rdfs:range :Manufacturer ;
            rdfs:comment "Identifies the manufacturer that reported the incident to EUDAMED."@en ;
            rdfs:label "reported by"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#severity
:severity rdf:type owl:ObjectProperty ;
          rdfs:domain :Risk ;
          rdfs:comment "The severity level of a risk."@en ;
          rdfs:label "severity"@en .


#################################################################
#    Data properties
#################################################################

###  https://aking1997.github.io/medtech-safety-ontology/doc#action_date
:action_date rdf:type owl:DatatypeProperty ;
             rdfs:comment "The date when the corrective action was initiated."@en ;
             rdfs:label "action_date"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#authorization_number
:authorization_number rdf:type owl:DatatypeProperty ;
                      rdfs:comment "The regulatory authorization number of the manufacturer."@en ;
                      rdfs:label "authorization_number"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#closure_date
:closure_date rdf:type owl:DatatypeProperty ;
              rdfs:comment "The date when the corrective action was officially closed."@en ;
              rdfs:label "closure_date"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#competent_authority
:competent_authority rdf:type owl:DatatypeProperty ;
                     rdfs:comment "The national authority overseeing the manufacturer."@en ;
                     rdfs:label "competent_authority"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#contact_email
:contact_email rdf:type owl:DatatypeProperty ;
               rdfs:comment "Contact email for the manufacturer."@en ;
               rdfs:label "contact_email"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#corrective_action_taken
:corrective_action_taken rdf:type owl:DatatypeProperty ;
                         rdfs:comment "Indicates if a corrective action was taken following the incident."@en ;
                         rdfs:label "corrective_action_taken"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#countries_affected
:countries_affected rdf:type owl:DatatypeProperty ;
                    rdfs:comment "List of countries affected by the incident or FSCA."@en ;
                    rdfs:label "countries_affected"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#country
:country rdf:type owl:DatatypeProperty ;
         rdfs:comment "The country of origin for the manufacturer."@en ;
         rdfs:label "country"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#country_reported
:country_reported rdf:type owl:DatatypeProperty ;
                  rdfs:comment "The country where the incident occurred."@en ;
                  rdfs:label "country_reported"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#description
:description rdf:type owl:DatatypeProperty ;
             rdfs:comment "A textual description of the event, risk, or action."@en ;
             rdfs:label "description"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#detection_date
:detection_date rdf:type owl:DatatypeProperty ;
                rdfs:comment "The date when the incident was first detected."@en ;
                rdfs:label "detection_date"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#device_id
:device_id rdf:type owl:DatatypeProperty ;
           rdfs:comment "The unique internal identifier for the device."@en ;
           rdfs:label "device_id"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#device_name
:device_name rdf:type owl:DatatypeProperty ;
             rdfs:comment "The commercial name of the medical device."@en ;
             rdfs:label "device_name"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#devices_affected
:devices_affected rdf:type owl:DatatypeProperty ;
                  rdfs:comment "The number of device units affected by a recall or alert."@en ;
                  rdfs:label "devices_affected"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#eudamed_fsca_ref
:eudamed_fsca_ref rdf:type owl:DatatypeProperty ;
                  rdfs:comment "The official EUDAMED reference number for the FSCA."@en ;
                  rdfs:label "eudamed_fsca_ref"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#eudamed_incident_ref
:eudamed_incident_ref rdf:type owl:DatatypeProperty ;
                      rdfs:comment "The official EUDAMED reference number for the incident."@en ;
                      rdfs:label "eudamed_incident_ref"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#eudamed_srn
:eudamed_srn rdf:type owl:DatatypeProperty ;
             rdfs:comment "The Single Registration Number of the manufacturer in EUDAMED."@en ;
             rdfs:label "eudamed_srn"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#event_date
:event_date rdf:type owl:DatatypeProperty ;
            rdfs:comment "The exact date the adverse event took place."@en ;
            rdfs:label "event_date"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#fsca_id
:fsca_id rdf:type owl:DatatypeProperty ;
         rdfs:comment "The unique identifier for the Field Safety Corrective Action."@en ;
         rdfs:label "fsca_id"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#imdrf_code
:imdrf_code rdf:type owl:DatatypeProperty ;
            rdfs:comment "The official IMDRF code identifying the type of risk or event."@en ;
            rdfs:label "imdrf_code"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#incident_id
:incident_id rdf:type owl:DatatypeProperty ;
             rdfs:comment "The unique identifier for the incident."@en ;
             rdfs:label "incident_id"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#intended_purpose
:intended_purpose rdf:type owl:DatatypeProperty ;
                  rdfs:comment "The medical purpose for which the device is intended."@en ;
                  rdfs:label "intended_purpose"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#is_active
:is_active rdf:type owl:DatatypeProperty ;
           rdfs:domain :ActiveDevice ;
           rdfs:comment "Boolean flag indicating if the device is active (powered)."@en ;
           rdfs:label "is_active"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#is_implantable
:is_implantable rdf:type owl:DatatypeProperty ;
                rdfs:comment "Boolean flag indicating if the device is implantable."@en ;
                rdfs:label "is_implantable"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#is_ivd
:is_ivd rdf:type owl:DatatypeProperty ;
        rdfs:comment "Boolean flag indicating if the device is an IVD."@en ;
        rdfs:label "is_ivd"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#is_reusable
:is_reusable rdf:type owl:DatatypeProperty ;
             rdfs:comment "Boolean flag indicating if the device is reusable."@en ;
             rdfs:label "is_reusable"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#manufacturer_id
:manufacturer_id rdf:type owl:DatatypeProperty ;
                 rdfs:comment "The unique identifier for the manufacturer."@en ;
                 rdfs:label "manufacturer_id"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#name
:name rdf:type owl:DatatypeProperty ;
      rdfs:comment "The name of the entity."@en ;
      rdfs:label "name"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#outcome
:outcome rdf:type owl:DatatypeProperty ;
         rdfs:comment "The clinical outcome of the patient following the incident."@en ;
         rdfs:label "outcome"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#patient_age
:patient_age rdf:type owl:DatatypeProperty ;
             rdfs:comment "The age of the patient involved in the incident."@en ;
             rdfs:label "patient_age"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#patient_sex
:patient_sex rdf:type owl:DatatypeProperty ;
             rdfs:comment "The biological sex of the patient."@en ;
             rdfs:label "patient_sex"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#probability
:probability rdf:type owl:DatatypeProperty ;
             rdfs:comment "The likelihood of the risk occurring."@en ;
             rdfs:label "probability"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#regulatory_framework
:regulatory_framework rdf:type owl:DatatypeProperty ;
                      rdfs:comment "The legal framework applicable to the device (e.g., MDR or IVDR)."@en ;
                      rdfs:label "regulatory_framework"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#report_date
:report_date rdf:type owl:DatatypeProperty ;
             rdfs:comment "The date when the incident was reported to authorities."@en ;
             rdfs:label "report_date"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#risk_category
:risk_category rdf:type owl:DatatypeProperty ;
               rdfs:comment "The overarching category of the risk."@en ;
               rdfs:label "risk_category"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#risk_class
:risk_class rdf:type owl:DatatypeProperty ;
            rdfs:comment "The regulatory risk classification of the device (e.g., Class III)."@en ;
            rdfs:label "risk_class"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#risk_id
:risk_id rdf:type owl:DatatypeProperty ;
         rdfs:comment "The unique identifier for the risk record."@en ;
         rdfs:label "risk_id"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#risk_name
:risk_name rdf:type owl:DatatypeProperty ;
           rdfs:comment "The specific name of the identified risk."@en ;
           rdfs:label "risk_name"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#scope
:scope rdf:type owl:DatatypeProperty ;
       rdfs:comment "The scope of affected products in an FSCA."@en ;
       rdfs:label "scope"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#status
:status rdf:type owl:DatatypeProperty ;
        rdfs:comment "The current status of the incident or FSCA (e.g., Open, Closed)."@en ;
        rdfs:label "status"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#udi_di
:udi_di rdf:type owl:DatatypeProperty ;
        rdfs:comment "The Unique Device Identifier - Device Identifier."@en ;
        rdfs:label "udi_di"@en .


#################################################################
#    Classes
#################################################################

###  http://xmlns.com/foaf/0.1/Organization
<http://xmlns.com/foaf/0.1/Organization> rdf:type owl:Class ;
                                         rdfs:comment "A corporate or administrative entity."@en ;
                                         rdfs:label "Organization"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#ActiveDevice
:ActiveDevice rdf:type owl:Class ;
              rdfs:subClassOf :Device ;
              owl:disjointWith :InVitroDiagnosticDevice ;
              rdfs:comment "A medical device that relies on a source of electrical energy or any source of power."@en ;
              rdfs:label "Active Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#ActiveImplant
:ActiveImplant rdf:type owl:Class ;
               rdfs:subClassOf :ImplantableDevice ;
               rdfs:comment "An implantable device that relies on an energy source."@en ;
               rdfs:label "Active Implant"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#ContaminationRisk
:ContaminationRisk rdf:type owl:Class ;
                   rdfs:subClassOf :Risk ;
                   rdfs:comment "Risk arising from biological or chemical contamination of the device."@en ;
                   rdfs:label "Contamination Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#CybersecurityRisk
:CybersecurityRisk rdf:type owl:Class ;
                   rdfs:subClassOf :Risk ;
                   rdfs:comment "Risk arising from software vulnerabilities or unauthorized access."@en ;
                   rdfs:label "Cybersecurity Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#Device
:Device rdf:type owl:Class ;
        rdfs:subClassOf [ rdf:type owl:Restriction ;
                          owl:onProperty :hasManufacturer ;
                          owl:cardinality "1"^^xsd:nonNegativeInteger
                        ] ;
        rdfs:comment "A medical device according to the MDR/IVDR regulatory framework."@en ;
        rdfs:label "Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#DiagnosticRisk
:DiagnosticRisk rdf:type owl:Class ;
                rdfs:subClassOf :Risk ;
                rdfs:comment "Risk related to false positives or false negatives in IVD devices."@en ;
                rdfs:label "Diagnostic Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#FSCA
:FSCA rdf:type owl:Class ;
      rdfs:subClassOf [ rdf:type owl:Restriction ;
                        owl:onProperty :addressesIncident ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ;
      rdfs:comment "Field Safety Corrective Action taken to mitigate a risk."@en ;
      rdfs:label "F S C A"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#ImplantableActiveDevice
:ImplantableActiveDevice rdf:type owl:Class ;
                         rdfs:subClassOf :ActiveDevice ;
                         rdfs:comment "An active medical device which is intended to be totally or partially introduced into the human body."@en ;
                         rdfs:label "Implantable Active Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#ImplantableDevice
:ImplantableDevice rdf:type owl:Class ;
                   rdfs:subClassOf :Device ;
                   rdfs:comment "A device intended to be totally introduced into the human body through clinical intervention."@en ;
                   rdfs:label "Implantable Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#InSituCorrection
:InSituCorrection rdf:type owl:Class ;
                  rdfs:subClassOf :FSCA ;
                  rdfs:comment "Action taken to correct or update a device without removing it from the user."@en ;
                  rdfs:label "In Situ Correction"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#InVitroDiagnosticDevice
:InVitroDiagnosticDevice rdf:type owl:Class ;
                         rdfs:subClassOf :Device ;
                         rdfs:comment "A medical device intended by the manufacturer for the examination of specimens derived from the human body."@en ;
                         rdfs:label "In Vitro Diagnostic Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#Incident
:Incident rdf:type owl:Class ;
          rdfs:subClassOf [ rdf:type owl:Restriction ;
                            owl:onProperty :associatedWithRisk ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :involvesDevice ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ,
                          [ rdf:type owl:Restriction ;
                            owl:onProperty :reportedBy ;
                            owl:cardinality "1"^^xsd:nonNegativeInteger
                          ] ;
          rdfs:comment "An adverse event or serious incident involving a medical device."@en ;
          rdfs:label "Incident"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#InfectionRisk
:InfectionRisk rdf:type owl:Class ;
               rdfs:subClassOf :Risk ;
               rdfs:comment "Risk of the patient developing an infection due to the device."@en ;
               rdfs:label "Infection Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#InjuryRisk
:InjuryRisk rdf:type owl:Class ;
            rdfs:subClassOf :Risk ;
            rdfs:comment "Risk of physical harm or tissue damage to the patient."@en ;
            rdfs:label "Injury Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#InterferenceRisk
:InterferenceRisk rdf:type owl:Class ;
                  rdfs:subClassOf :Risk ;
                  rdfs:comment "Risk due to electromagnetic or environmental interference."@en ;
                  rdfs:label "Interference Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#MalfunctionRisk
:MalfunctionRisk rdf:type owl:Class ;
                 rdfs:subClassOf :Risk ;
                 rdfs:comment "Risk of the device failing to perform its intended function."@en ;
                 rdfs:label "Malfunction Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#Manufacturer
:Manufacturer rdf:type owl:Class ;
              rdfs:subClassOf <http://xmlns.com/foaf/0.1/Organization> ;
              rdfs:comment "The corporate entity responsible for manufacturing the medical device."@en ;
              rdfs:label "Manufacturer"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#MaterialRisk
:MaterialRisk rdf:type owl:Class ;
              rdfs:subClassOf :Risk ;
              rdfs:comment "Risk related to the degradation, wear, or toxicity of the device materials."@en ;
              rdfs:label "Material Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#Recall
:Recall rdf:type owl:Class ;
        rdfs:subClassOf :FSCA ;
        rdfs:comment "Action to return the medical device to the manufacturer or supplier."@en ;
        rdfs:label "Recall"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#Risk
:Risk rdf:type owl:Class ;
      rdfs:subClassOf [ rdf:type owl:Restriction ;
                        owl:onProperty :severity ;
                        owl:cardinality "1"^^xsd:nonNegativeInteger
                      ] ;
      rdfs:comment "A potential hazard or clinical risk associated with the use of a device."@en ;
      rdfs:label "Risk"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#SafetyAlert
:SafetyAlert rdf:type owl:Class ;
             rdfs:subClassOf :FSCA ;
             rdfs:comment "Communication sent to users detailing important safety information."@en ;
             rdfs:label "Safety Alert"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#SelfTestDevice
:SelfTestDevice rdf:type owl:Class ;
                rdfs:subClassOf :InVitroDiagnosticDevice ;
                rdfs:comment "An IVD device intended by the manufacturer to be able to be used by lay persons."@en ;
                rdfs:label "Self Test Device"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#SeriousIncident
:SeriousIncident rdf:type owl:Class ;
                 rdfs:subClassOf :Incident ;
                 rdfs:comment "An incident that directly or indirectly led to death or a serious deterioration in the state of health."@en ;
                 rdfs:label "Serious Incident"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#UserNotice
:UserNotice rdf:type owl:Class ;
            rdfs:subClassOf :FSCA ;
            rdfs:comment "A formal notification to users regarding device usage instructions."@en ;
            rdfs:label "User Notice"@en .


#################################################################
#    Individuals
#################################################################

###  http://dbpedia.org/resource/Medtronic
<http://dbpedia.org/resource/Medtronic> rdf:type owl:NamedIndividual ;
                                        owl:sameAs :MAN-001 .


###  https://aking1997.github.io/medtech-safety-ontology/doc#MAN-001

###  http://dbpedia.org/resource/Product_recall
<http://dbpedia.org/resource/Product_recall> rdf:type owl:NamedIndividual ;
                                             owl:sameAs :FSCA-001 .


###  https://aking1997.github.io/medtech-safety-ontology/doc#FSCA-001

###  http://dbpedia.org/resource/Ventricular_assist_device
<http://dbpedia.org/resource/Ventricular_assist_device> rdf:type owl:NamedIndividual ;
                                                        owl:sameAs :DEV-001 .


###  https://aking1997.github.io/medtech-safety-ontology/doc#DEV-001

###  https://aking1997.github.io/medtech-safety-ontology/doc#DEV-001
:DEV-001 rdf:type owl:NamedIndividual ,
                  :ImplantableActiveDevice ;
         :hasManufacturer :MAN-001 ;
         :device_id "DEV-001" ;
         :device_name "HeartMate 3 LVAD" ;
         :is_active "true"^^xsd:boolean ;
         :is_implantable "true"^^xsd:boolean ;
         rdfs:comment "Instance of an active implantable device from dispositivos.csv."@en ;
         rdfs:label "HeartMate 3 LVAD"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#FSCA-001
:FSCA-001 rdf:type owl:NamedIndividual ,
                   :SafetyAlert ;
          :addressesIncident :INC-001 ;
          :action_date "2024-02-01T00:00:00"^^xsd:dateTime ;
          :fsca_id "FSCA-001" ;
          :status "Open" ;
          rdfs:comment "Field safety corrective action from acciones_correctivas.csv."@en ;
          rdfs:label "Safety Alert HeartMate 3"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#INC-001
:INC-001 rdf:type owl:NamedIndividual ,
                  :SeriousIncident ;
         :associatedWithRisk :RSK-003 ;
         :involvesDevice :DEV-001 ;
         :reportedBy :MAN-001 ;
         :incident_id "INC-001" ;
         :patient_age 58 ;
         :report_date "2024-01-15T00:00:00"^^xsd:dateTime ;
         rdfs:comment "Incident report extracted from incidentes.csv."@en ;
         rdfs:label "Serious patient injury - embolic stroke"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#MAN-001
:MAN-001 rdf:type owl:NamedIndividual ,
                  :Manufacturer ;
         :manufacturesDevice :DEV-001 ;
         :country "Ireland" ;
         :manufacturer_id "MAN-001" ;
         :name "Medtronic plc" ;
         rdfs:comment "Instance representing Medtronic plc, extracted from fabricantes.csv."@en ;
         rdfs:label "Medtronic plc"@en .


###  https://aking1997.github.io/medtech-safety-ontology/doc#RSK-003
:RSK-003 rdf:type owl:NamedIndividual ,
                  :InjuryRisk ;
         :risk_id "RSK-003" ;
         rdfs:comment "Risk instance representing device-related thrombosis from riesgos.csv."@en ;
         rdfs:label "Thrombosis - device-related"@en .


###  Generated by the OWL API (version 5.1.18) https://github.com/owlcs/owlapi/