{
  "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": {
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    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
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      "manufacturer_contact_state": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Other",
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      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "19970701",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "19970604",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "UNKNOWN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
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      "distributor_zip_code_ext": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "19970708",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "101470",
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          "date_removed_flag": "Not available",
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          "generic_name": "EXAMINATION GLOVE",
          "manufacturer_d_name": "MAXXIM MEDICAL CANADA, LTD.",
          "manufacturer_d_address_1": "2460 SOUTH SHERIDAN WAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MISSISSAUGA, ONTARIO",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "CA",
          "manufacturer_d_postal_code": "L5J 2M8",
          "model_number": "NA",
          "catalog_number": "484003",
          "lot_number": "707SC6",
          "other_id_number": "NA",
          "device_operator": "LAY USER/PATIENT",
          "device_availability": "No",
          "device_report_product_code": "LYZ",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "baseline_510_k__flag": "Y",
          "baseline_510_k__number": "K944182",
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          "openfda": {
            "device_name": "Vinyl Patient Examination Glove",
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      "reporter_state_code": "NJ",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "date_received": "19970701",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "UNKNOWN",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": ""
        }
      ],
      "distributor_city": "",
      "date_report": "19970627",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "103125",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "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": "19261397",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "COMPLAINANT CARES FOR HER MOTHER IN THE HOME AND USES SENSICARE EXAMINATION GLOVES. COMPLAINANT ALLEGES THAT SHE EXPERIENCED A SEVERE ALLERGIC REACTION DURING USE OF THE EXAM GLOVE. THE REPORTED REACTIONS WERE: HANDS-BURNING AND SWOLLEN. EYES-RED SWOLLEN, AND ITCHY."
        }
      ],
      "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": ""
    }
  ]
}