openFDA · Schema

Device Adverse Event

FDAFood and Drug AdministrationDrug SafetyAdverse EventsDrug LabelsRecallsMedical DevicesFood SafetyTobaccoPublic HealthOpen DataGovernmentRegulatoryFAERSSPL

Properties

Name Type Description
adverse_event_flag string
date_facility_aware string
date_manufacturer_received string
date_of_event string
date_received string
date_report string
date_report_to_fda string
date_report_to_manufacturer string
date_added string
date_changed string
device array
device_date_of_manufacturer string
distributor_address_1 string
distributor_address_2 string
distributor_city string
distributor_name string
distributor_state string
distributor_zip_code string
distributor_zip_code_ext string
event_key string
event_location string
event_type string
expiration_date_of_device string
health_professional string
initial_report_to_fda string
manufacturer_address_1 string
manufacturer_address_2 string
manufacturer_city string
manufacturer_contact_address_1 string
manufacturer_contact_address_2 string
manufacturer_contact_area_code string
manufacturer_contact_city string
manufacturer_contact_country string
manufacturer_contact_exchange string
manufacturer_contact_extension string
manufacturer_contact_f_name string
manufacturer_contact_l_name string
manufacturer_contact_pcity string
manufacturer_contact_pcountry string
manufacturer_contact_phone_number string
manufacturer_contact_plocal string
manufacturer_contact_postal_code string
manufacturer_contact_state string
manufacturer_contact_t_name string
manufacturer_contact_zip_code string
manufacturer_contact_zip_ext string
manufacturer_country string
manufacturer_g1_address_1 string
manufacturer_g1_address_2 string
manufacturer_g1_city string
manufacturer_g1_country string
manufacturer_g1_name string
manufacturer_g1_postal_code string
manufacturer_g1_state string
manufacturer_g1_zip_code string
manufacturer_g1_zip_code_ext string
manufacturer_link_flag string
manufacturer_name string
manufacturer_postal_code string
manufacturer_state string
manufacturer_zip_code string
manufacturer_zip_code_ext string
mdr_report_key string
mdr_text array
noe_summarized string
number_devices_in_event string
number_patients_in_event string
patient array
previous_use_code string
product_problem_flag string
product_problems array
remedial_action string
removal_correction_number string
report_date string
report_number string
report_source_code string
report_to_fda string
report_to_manufacturer string
reporter_occupation_code string
reprocessed_and_reused_flag string
single_use_flag string
source_type array
type_of_report array
View JSON Schema on GitHub

JSON Schema

device-adverse-event.json Raw ↑ 
{
  "$schema": "http://json-schema.org/draft-03/schema",
  "properties": {
    "adverse_event_flag": {
      "type": "string"
    },
    "date_facility_aware": {
        "type": "string",
        "format": "date"
    },
    "date_manufacturer_received": {
      "type": "string",
      "format": "date"
    },
    "date_of_event": {
      "type": "string",
      "format": "date"
    },
    "date_received": {
      "type": "string",
      "format": "date"
    },
    "date_report": {
      "type": "string",
      "format": "date"
    },
    "date_report_to_fda": {
      "type": "string",
      "format": "date"
    },
    "date_report_to_manufacturer": {
      "type": "string",
      "format": "date"
    },
    "date_added": {
      "type": "string",
      "format": "date"
    },
    "date_changed": {
      "type": "string",
      "format": "date"
    },
    "device": {
      "items": {
        "properties": {
          "baseline_510_k__exempt_flag": {
            "type": "string"
          },
          "baseline_510_k__flag": {
            "type": "string"
          },
          "baseline_510_k__number": {
            "type": "string"
          },
          "baseline_brand_name": {
            "type": "string"
          },
          "baseline_catalog_number": {
            "type": "string"
          },
          "baseline_date_ceased_marketing": {
            "type": "string",
            "format": "date"
          },
          "baseline_date_first_marketed": {
            "type": "string",
            "format": "date"
          },
          "baseline_device_family": {
            "type": "string"
          },
          "baseline_generic_name": {
            "type": "string"
          },
          "baseline_model_number": {
            "type": "string"
          },
          "baseline_other_id_number": {
            "type": "string"
          },
          "baseline_pma_flag": {
            "type": "string"
          },
          "baseline_pma_number": {
            "type": "string"
          },
          "baseline_preamendment_flag": {
            "type": "string"
          },
          "baseline_shelf_life_contained": {
            "type": "string"
          },
          "baseline_shelf_life_in_months": {
            "type": "string"
          },
          "baseline_transitional_flag": {
            "type": "string"
          },
          "brand_name": {
            "type": "string"
          },
          "catalog_number": {
            "type": "string"
          },
          "date_received": {
            "type": "string",
            "format": "date"
          },
          "date_removed_flag": {
            "type": "string"
          },
          "date_returned_to_manufacturer": {
            "type": "string",
            "format": "date"
          },
          "device_age_text": {
            "type": "string"
          },
          "device_availability": {
            "type": "string"
          },
          "device_evaluated_by_manufacturer": {
            "type": "string"
          },
          "device_event_key": {
            "type": "string"
          },
          "device_operator": {
            "type": "string"
          },
          "device_report_product_code": {
            "type": "string"
          },
          "device_sequence_number": {
            "type": "string"
          },
          "expiration_date_of_device": {
            "type": "string",
            "format": "date"
          },
          "generic_name": {
            "type": "string"
          },
          "implant_flag": {
            "type": "string"
          },
          "lot_number": {
            "type": "string"
          },
          "manufacturer_d_address_1": {
            "type": "string"
          },
          "manufacturer_d_address_2": {
            "type": "string"
          },
          "manufacturer_d_city": {
            "type": "string"
          },
          "manufacturer_d_country": {
            "type": "string"
          },
          "manufacturer_d_name": {
            "type": "string"
          },
          "manufacturer_d_postal_code": {
            "type": "string"
          },
          "manufacturer_d_state": {
            "type": "string"
          },
          "manufacturer_d_zip_code": {
            "type": "string"
          },
          "manufacturer_d_zip_code_ext": {
            "type": "string"
          },
          "model_number": {
            "type": "string"
          },
          "openfda": {
            "properties": {
              "device_class": {
                "type": "string"
              },
              "device_name": {
                "type": "string"
              },
              "fei_number": {
                "items": {
                  "type": "string"
                },
                "type": "array"
              },
              "medical_specialty_description": {
                "type": "string"
              },
              "registration_number": {
                "items": {
                  "type": "string"
                },
                "type": "array"
              },
              "regulation_number": {
                "items": {
                  "type": "string"
                },
                "type": "array"
              }
            },
            "type": "object"
          },
          "other_id_number": {
            "type": "string"
          }
        },
        "type": "object"
      },
      "type": "array"
    },
    "device_date_of_manufacturer": {
      "type": "string",
      "format": "date"
    },
    "distributor_address_1": {
      "type": "string"
    },
    "distributor_address_2": {
      "type": "string"
    },
    "distributor_city": {
      "type": "string"
    },
    "distributor_name": {
      "type": "string"
    },
    "distributor_state": {
      "type": "string"
    },
    "distributor_zip_code": {
      "type": "string"
    },
    "distributor_zip_code_ext": {
      "type": "string"
    },
    "event_key": {
      "type": "string"
    },
    "event_location": {
      "type": "string"
    },
    "event_type": {
      "type": "string"
    },
    "expiration_date_of_device": {
      "type": "string",
      "format": "date"
    },
    "health_professional": {
      "type": "string"
    },
    "initial_report_to_fda": {
      "type": "string"
    },
    "manufacturer_address_1": {
      "type": "string"
    },
    "manufacturer_address_2": {
      "type": "string"
    },
    "manufacturer_city": {
      "type": "string"
    },
    "manufacturer_contact_address_1": {
      "type": "string"
    },
    "manufacturer_contact_address_2": {
      "type": "string"
    },
    "manufacturer_contact_area_code": {
      "type": "string"
    },
    "manufacturer_contact_city": {
      "type": "string"
    },
    "manufacturer_contact_country": {
      "type": "string"
    },
    "manufacturer_contact_exchange": {
      "type": "string"
    },
    "manufacturer_contact_extension": {
      "type": "string"
    },
    "manufacturer_contact_f_name": {
      "type": "string"
    },
    "manufacturer_contact_l_name": {
      "type": "string"
    },
    "manufacturer_contact_pcity": {
      "type": "string"
    },
    "manufacturer_contact_pcountry": {
      "type": "string"
    },
    "manufacturer_contact_phone_number": {
      "type": "string"
    },
    "manufacturer_contact_plocal": {
      "type": "string"
    },
    "manufacturer_contact_postal_code": {
      "type": "string"
    },
    "manufacturer_contact_state": {
      "type": "string"
    },
    "manufacturer_contact_t_name": {
      "type": "string"
    },
    "manufacturer_contact_zip_code": {
      "type": "string"
    },
    "manufacturer_contact_zip_ext": {
      "type": "string"
    },
    "manufacturer_country": {
      "type": "string"
    },
    "manufacturer_g1_address_1": {
      "type": "string"
    },
    "manufacturer_g1_address_2": {
      "type": "string"
    },
    "manufacturer_g1_city": {
      "type": "string"
    },
    "manufacturer_g1_country": {
      "type": "string"
    },
    "manufacturer_g1_name": {
      "type": "string"
    },
    "manufacturer_g1_postal_code": {
      "type": "string"
    },
    "manufacturer_g1_state": {
      "type": "string"
    },
    "manufacturer_g1_zip_code": {
      "type": "string"
    },
    "manufacturer_g1_zip_code_ext": {
      "type": "string"
    },
    "manufacturer_link_flag": {
      "type": "string"
    },
    "manufacturer_name": {
      "type": "string"
    },
    "manufacturer_postal_code": {
      "type": "string"
    },
    "manufacturer_state": {
      "type": "string"
    },
    "manufacturer_zip_code": {
      "type": "string"
    },
    "manufacturer_zip_code_ext": {
      "type": "string"
    },
    "mdr_report_key": {
      "type": "string"
    },
    "mdr_text": {
      "items": {
        "properties": {
          "date_report": {
            "type": "string",
            "format": "date"
          },
          "mdr_text_key": {
            "type": "string"
          },
          "patient_sequence_number": {
            "type": "string"
          },
          "text": {
            "type": "string"
          },
          "text_type_code": {
            "type": "string"
          }
        },
        "type": "object"
      },
      "type": "array"
    },
    "noe_summarized": {
      "type": "string"
    },
    "number_devices_in_event": {
      "type": "string"
    },
    "number_patients_in_event": {
      "type": "string"
    },
    "patient": {
      "items": {
        "properties": {
          "date_received": {
            "type": "string",
            "format": "date"
          },
          "patient_sequence_number": {
            "type": "string"
          },
          "sequence_number_outcome": {
            "type": "string"
          },
          "sequence_number_treatment": {
            "type": "string"
          },
          "patient_problems": {
            "items": {
              "type": "string"
            },
            "type": "array"
          },
          "patient_age": {
             "type": "string"
          },
          "patient_sex": {
             "type": "string"
          },
          "patient_weight": {
            "type": "string"
          },
          "patient_ethnicity": {
            "type": "string"
          },
          "patient_race": {
             "type": "string"
          }
        },
        "type": "object"
      },
      "type": "array"
    },
    "previous_use_code": {
      "type": "string"
    },
    "product_problem_flag": {
      "type": "string"
    },
    "product_problems": {
      "items": {
        "type": "string"
      },
      "type": "array"
    },
    "remedial_action": {
      "type": "string"
    },
    "removal_correction_number": {
      "type": "string"
    },
    "report_date": {
        "type": "string",
        "format": "date"
    },
    "report_number": {
      "type": "string"
    },
    "report_source_code": {
      "type": "string"
    },
    "report_to_fda": {
      "type": "string"
    },
    "report_to_manufacturer": {
      "type": "string"
    },
    "reporter_occupation_code": {
      "type": "string"
    },
    "reprocessed_and_reused_flag": {
      "type": "string"
    },
    "single_use_flag": {
      "type": "string"
    },
    "source_type": {
      "items": {
        "type": "string"
      },
      "type": "array"
    },
    "type_of_report": {
      "items": {
        "type": "string"
      },
      "type": "array"
    }
  },
  "type": "object"
}