{
  "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/",
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          "implant_flag": "",
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          "generic_name": "STERILE SURGICAL GOWN",
          "manufacturer_d_name": "AVENT DE HONDURAS, S.A. DE C.V.",
          "manufacturer_d_address_1": "CARRETERA TEGUCIGALPA,",
          "manufacturer_d_address_2": "VILLANEVA",
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      "date_changed": "20250729",
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          "patient_problems": [
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      "event_key": "",
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      "manufacturer_contact_city": "",
      "mdr_report_key": "1000568",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080118",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "mdr_text": [
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          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED TO THE MANUFACTURER BY SALES REPRESENTATIVE THAT DURING A SURGICAL PROCEDURE ON A PATIENT, A GOWN WORN BY THE SURGEON WAS SATURATED WITH A PATIENT'S BLOOD WHO WAS HEPATITIS C POSITIVE. IN A QUESTIONNAIRE FILLED OUT BY THE WEARER, IT WAS ALSO NOTED THAT BLOOD WAS VISIBLE ON THE WEARER'S SCRUBS AND ARMS AND CHEST WERE EXPOSED. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS A CONSEQUENCE OF THE STRIKE THROUGH. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED."
        },
        {
          "mdr_text_key": "8093482",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE MANUFACTURER REQUESTED THE SAMPLE FOR EXAMINATION, BUT THE USER REPORTED THAT A SAMPLE WAS UNABLE TO BE RETURNED. INVESTIGATION BY THE MANUFACTURER OF THE ALLEGED EVENT WAS UNABLE TO DETERMINE A CAUSE FOR THE STRIKE THROUGH. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE CORRESPONDING MANUFACTURED LOT IDENTIFIED NO DOCUMENTED MANUFACTURING ANOMALIES. A FOLLOW-UP REPORT WILL BE PROVIDED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT & MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS."
        }
      ],
      "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": ""
    }
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}