{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1587
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "N",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "MW5094742",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200528",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200511",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        ""
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200529",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "559072",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200528",
          "brand_name": "PRIMARY CARE BY MDP ECG MONITORING ELECTRODES",
          "generic_name": "ELECTRODE, ELECTROCARDIOGRAPH",
          "manufacturer_d_name": "GRAPHIC CONTROLS DBA NISSHA MEDICAL TECHNOLOGIES/VERMED/BIOM",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "REF V8850",
          "catalog_number": "",
          "lot_number": "46519V25",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "DRX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Electrode, Electrocardiograph",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2360",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Patient-Device Incompatibility"
      ],
      "reporter_state_code": "TN",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250826",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200528",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "51 YR",
          "patient_sex": "",
          "patient_weight": "70",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Itching Sensation",
            "Pain",
            "Peeling",
            "Skin Irritation",
            "Burning Sensation",
            "Discharge",
            "Reaction",
            "Itching Sensation",
            "Pain",
            "Peeling",
            "Skin Irritation",
            "Burning Sensation",
            "Discharge",
            "Reaction"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200527",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10100861",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "193313544",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "SKIN REACTION (WELTS, RASH, ITCHING, OOZING, BURNING PAIN) TO ELECTRODES USED FOR A 14 DAY HOLTER MONITOR. THE MONITORING COMPANY SENT ME THESE ELECTRODES STATING THEY WERE FOR SENSITIVE SKIN. I CHANGED THE ELECTRODES AND MOVE THEM TO A NEW PLACE EVERY 24 HOURS. TWO WEEKS AFTER COMPLETING MY MONITORING I STILL HAVE DRY PEELING SKIN. I CAN PROVIDE PICTURES OF THE SKIN REACTION. FDA SAFETY REPORT ID #: (B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}