This page is part of the FHIR Specification ~~(v3.3.0:~~ (v3.5.0: R4 Ballot ~~2).~~ #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions
Medicinalproductdevicespec-example.json

Biomedical Research and Regulation Work Group
Maturity Level : N/A
Ballot Status : Informative
Compartments : Not linked to any defined compartments
Raw JSON ( canonical form + also see JSON Format Specification )
Example of medicinalproductdevicespec
{
  "resourceType": "AdverseEvent",

  "resourceType": "MedicinalProductDeviceSpec",

  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: 49476534</p><p><b>actuality</b>: actual</p><p><b>event</b>: This was a mild rash on the left forearm <span>(Details : {SNOMED CT code '304386008' = 'O/E - itchy rash', given as 'O/E - itchy rash'})</span></p><p><b>subject</b>: <a>Patient/example</a></p><p><b>date</b>: 29/01/2017 12:34:56 PM</p><p><b>seriousness</b>: Non-serious <span>(Details : {http://hl7.org/fhir/adverse-event-seriousness code 'Non-serious' = 'Non-serious', given as 'Non-serious'})</span></p><p><b>severity</b>: Mild <span>(Details : {http://hl7.org/fhir/adverse-event-severity code 'Mild' = 'Mild', given as 'Mild'})</span></p><p><b>recorder</b>: <a>Practitioner/example</a></p><h3>SuspectEntities</h3><table><tr><td>-</td><td><b>Instance</b></td></tr><tr><td>*</td><td><a>Medication/example</a></td></tr></table></div>"

    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><p><b>identifier</b>: Device.DeviceIdentifier.extension</p><p><b>type</b>: {Device.DeviceType} <span>(Details : {http://ema.europa.eu/example/deviceType code '{Device.DeviceType}' = '{Device.DeviceType})</span></p><p><b>tradeName</b>: Device Trade Name</p><p><b>quantity</b>: 2 1</p><p><b>listingNumber</b>: Device.DeviceListingNumber</p><p><b>modelNumber</b>: Device.ModelNumber</p><p><b>sterilityIndicator</b>: {Device.SterilityIndicator} <span>(Details : {http://ema.europa.eu/example/deviceSterilityIndicator code '{Device.SterilityIndicator}' = '{Device.SterilityIndicator})</span></p><p><b>sterilisationRequirement</b>: {Device.SterilisationRequirementIndicator} <span>(Details : {http://ema.europa.eu/example/deviceSterilisationRequirementIndicator code '{Device.SterilisationRequirementIndicator}' = '{Device.SterilisationRequirementIndicator})</span></p><p><b>usage</b>: {Device.DeviceUsage} <span>(Details : {http://ema.europa.eu/example/deviceUsage code '{Device.DeviceUsage}' = '{Device.DeviceUsage})</span></p><p><b>nomenclature</b>: {DeviceNomenclature.NomenclatureValue} <span>(Details : {http://ema.europa.eu/example/deviceNomenclatureNomenclature code '{DeviceNomenclature.NomenclatureValue}' = '{DeviceNomenclature.NomenclatureValue})</span></p><p><b>physicalCharacteristics</b>: </p><p><b>Exception generating Narrative: Unknown type ProdCharacteristic</b></p></div>"

  },
  "identifier": {
    "system": "http://acme.com/ids/patients/risks",
    "value": "49476534"

    "system": "http://ema.europa.eu/example/DeviceDeviceIdentifierRoot",
    "value": "Device.DeviceIdentifier.extension"

  },
  "actuality": "actual",
  "event": {

  "type": {

    "coding": [
      {
        "system": "http://snomed.info/sct",
        "code": "304386008",
        "display": "O/E - itchy rash"

        "system": "http://ema.europa.eu/example/deviceType",
        "code": "{Device.DeviceType}"

      }
    ],
    "text": "This was a mild rash on the left forearm"

    ]

  },
  "subject": {
    "reference": "Patient/example"

  "tradeName": "Device Trade Name",
  "quantity": {
    "value": 2,
    "unit": "1"

  },
  "date": "2017-01-29T12:34:56+00:00",
  "seriousness": {

  "listingNumber": "Device.DeviceListingNumber",
  "modelNumber": "Device.ModelNumber",
  "sterilityIndicator": {

    "coding": [
      {
        "system": "http://hl7.org/fhir/adverse-event-seriousness",
        "code": "Non-serious",
        "display": "Non-serious"

        "system": "http://ema.europa.eu/example/deviceSterilityIndicator",
        "code": "{Device.SterilityIndicator}"

      }
    ]
  },
  "severity": {

  "sterilisationRequirement": {

    "coding": [
      {
        "system": "http://hl7.org/fhir/adverse-event-severity",
        "code": "Mild",
        "display": "Mild"

        "system": "http://ema.europa.eu/example/deviceSterilisationRequirementIndicator",
        "code": "{Device.SterilisationRequirementIndicator}"

      }
    ]
  },
  "recorder": {
    "reference": "Practitioner/example"

  "usage": {
    "coding": [
      {
        "system": "http://ema.europa.eu/example/deviceUsage",
        "code": "{Device.DeviceUsage}"
      }
    ]

  },
  "suspectEntity": [

  "nomenclature": [

    {
      "instance": {
        "reference": "Medication/example"

      "coding": [
        {
          "system": "http://ema.europa.eu/example/deviceNomenclatureNomenclature",
          "code": "{DeviceNomenclature.NomenclatureValue}"
        }
      ]
    }
  ],
  "physicalCharacteristics": {
    "height": {
      "value": 99,
      "unit": "mm"
    },
    "width": {
      "value": 100,
      "unit": "mm"
    },
    "depth": {
      "value": 10,
      "unit": "mm"
    },
    "weight": {
      "value": 100,
      "unit": "g"
    },
    "nominalVolume": {
      "value": 100,
      "unit": "cm3"
    },
    "externalDiameter": {
      "value": 100,
      "unit": "mm"
    },
    "shape": "{PhysicalCharacteristic.Shape}",
    "color": [
      "{PhysicalCharacteristic.Colour}"
    ],
    "imprint": [
      "{PhysicalCharacteristic.Imprint}"
    ],
    "scoring": {
      "coding": [
        {
          "system": "http://ema.europa.eu/example/physicalCharacteristicScoring",
          "code": "{PhysicalCharacteristic.Scoring}"
        }
      ]
    }
  },
  "batchIdentifier": [
    {
      "value": "Device-BatchNumber",
      "period": {
        "end": "2020-02-02"

      }
    }
  ],
  "material": [
    {
      "substance": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/deviceMaterial",
            "code": "{Device.Material}"
          }
        ]
      },
      "alternate": true,
      "allergenicIndicator": false
    },
    {
      "substance": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/deviceMaterial",
            "code": "{Device.Material}"
          }
        ]
      },
      "alternate": false,
      "allergenicIndicator": true
    }

  ]
}
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.