{
  "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": "2026-09-08",
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          "manufacturer_d_address_2": "",
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      "date_changed": "20250804",
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          "sequence_number_treatment": [
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      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20131021",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3420063",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20131017",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
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      "mdr_text": [
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          "mdr_text_key": "3881844",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PATIENT CAME IN ELECTIVELY FOR ROBOTIC COLPOSUSPENSION WITH MESH, TENSION-FREE VAGINAL TAPE (TVT),  ANTERIOR POSTERIOR (AP) REPAIR. DURING THE PROCEDURE VASCULAR SURGERY HAD TO BE CALLED EMERGENTLY TO THE OPERATING ROOM TO ASSESS PATIENT WHO HAD MASSIVE BLEEDING DURING THE ROBOTIC PROCEDURE. THE ABDOMEN HAD BEEN OPENED BY THE PRIMARY SURGEON AND PRESSURE WAS BEING USED TO CONTROL THE BLEEDING. THE PATIENT HAD TO HAVE HER ABDOMEN OPENED WITH A MIDLINE INCISION FOR REPAIR OF LEFT ILIAC VEIN. AFTER EXPOSURE OF THE AREA MULTIPLE SMALL VENOTOMIES IN THE LEFT ILIAC VEIN WERE NOTED ADJACENT TO AN AREA CONTAINING GORTEX SUTURE AND MESH. THESE AREAS WERE REPAIRED."
        }
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}