{
  "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": "2026-07-07",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 56658
    }
  },
  "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": "Malfunction",
      "report_number": "MW5094263",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200424",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200422",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "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": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "462610",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200424",
          "brand_name": "SURGICAL MASK",
          "generic_name": "MASK, SURGICAL",
          "manufacturer_d_name": "TRAVERSE BAY MANUFACTURING",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ELK RAPIDS",
          "manufacturer_d_state": "MI",
          "manufacturer_d_zip_code": "49629",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "49629",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Yes",
          "device_report_product_code": "FXX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Mask, Surgical",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4040",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Product Quality Problem"
      ],
      "reporter_state_code": "MI",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250814",
      "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": "20200424",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200422",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000560",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "189163593",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "TRAVERSE BAY MANUFACTURING IN (B)(6) IS SELLING FAULTY SURGICAL MASKS. THEY CLAIM \"THE MATERIALS MEET AAMI PB 70 LEVEL IV STANDARDS. (THE HIGHEST VIRAL BARRIER LEVEL FOR A BREATHABLE MATERIAL)\". AAMI LEVEL IV IS FOR SURGICAL GOWNS, NOT MASKS. THE NURSING HOME I WORK IN BOUGHT THESE MASKS FOR THE STAFF. THESE MASKS PROVIDE NO FILTRATION OF BACTERIA OR VIRUSES. THE DIFFERENTIAL PRESSURE (DELTA P) IS TOO HIGH FOR ANY POSSIBLE FILTRATION TO OCCUR. ALL INHALED AND EXHALED AIR ESCAPES THE PERIMETER OF THE MASK RATHER THAN THROUGH IT. THE MATERIAL USED TO MAKE THE MASKS IS APPROPRIATE FOR SURGICAL GOWNS, BUT IS COMPLETELY INAPPROPRIATE FOR SURGICAL MASKS. THEY ARE SELLING THESE MASK TO THE PUBLIC AND ENDANGERING THEM. PLEASE ASK THEM TO CEASE AND DESIST, AND RECALL THESE FAULTY MASKS. 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": ""
    }
  ]
}