{
  "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",
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      "manufacturer_contact_zip_ext": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
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      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "467312",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "COVER, BACK TABLE, LG 54X100\"",
          "generic_name": "BACK TABLE COVER",
          "manufacturer_d_name": "NOVO HEALTH SERVICES TN",
          "manufacturer_d_address_1": "6024 CENTURY OAKS DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "CHATTANOOGA, TN",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
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          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
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          "catalog_number": "3020",
          "lot_number": "",
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          "device_availability": "No",
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          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Drape, Surgical, Antimicrobial",
            "medical_specialty_description": "General, Plastic Surgery",
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        }
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        "No Apparent Adverse Event"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "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": "20200427",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
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          "patient_age": "52 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
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            "Missing Value Reason",
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            "Missing Value Reason"
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        }
      ],
      "distributor_city": "",
      "date_report": "20200421",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000753",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200408",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "N",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "204761035",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2020, THE END-USER REPORTED A STRIKETHROUGH AT THE END OF THE PROCEDURE WHILE USING A REUSABLE LEVEL IV BACK TABLE COVER. THE FACILITY WAS NOTIFIED OF THE CONCERN ON 04/10/20. THE BACK TABLE COVER WAS NOT SENT BACK TO THE FACILITY TO COMPLETE AN INVESTIGATION; THEREFORE, A DEFINITIVE ROOT CAUSE OR VERIFICATION OF THE STRIKETHROUGH COULD NOT BE DETERMINED. THE FACILITY TOOK THE FOLLOWING ACTIONS: AWARENESS DOCUMENTED TRAINING WAS PROVIDED TO THE EMPLOYEES. RANDOM BARRIER TESTING OF BACK TABLE COVERS COMPLETED, WITH NO ISSUES NOTED. REVIEW OF PROCESSES AND PROCEDURES, NO UPDATES NEEDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED."
        },
        {
          "mdr_text_key": "204761036",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2020 END USER REPORTED A STRIKETHROUGH WITH A REUSABLE BACK TABLE COVER. THE SURGICAL SCRUB WAS BREAKING DOWN THE SET-UP AND NOTICED A THE WICKING OCCURED UNDER THE BASIN. THE SURGEON WAS NOTIFIED OF THE CONTAIMINATION."
        }
      ],
      "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": ""
    }
  ]
}