{
  "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_contact_zip_ext": "",
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          "manufacturer_d_address_2": "",
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      "date_changed": "20250724",
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          "sequence_number_treatment": [
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          ],
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          "patient_sex": "",
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          "patient_ethnicity": "",
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      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20131021",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3420104",
      "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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      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "adverse_event_flag": "Y",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3792589",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PHYSICIAN WAS PERFORMING A ROBOTIC HYSTERECTOMY. SHE REQUESTED TO PREPARE FOR AN OPEN PROCEDURE. THE STAFF OBSERVED ON THE MONITOR THAT THERE WAS SOME BLEEDING. WE BEGAN GATHERING ITEMS TO OPEN. PHYSICIAN REQUESTED A SUTURE AND THE BLEEDING SUBSIDED. SHE PUT A STITCH WHERE THE HEMATOMA WAS TO SEE IF IT WAS GETTING ANY BIGGER. IT APPEARED NOT TO. WE DID NOT GO OPEN. SHE THEN FINISHED THE PROCEDURE AND CHECKED AGAIN FOR BLEEDING AND CHECKED THE HEMATOMA AREA, IT SEEMED THE SAME AND THEN SHE CLOSED. PATIENT WAS TRANSPORTED TO RECOVERY. HOWEVER IT WAS REPORTED TO US LAST WEEK THAT THIS PATIENT HAD OTHER COMPLICATIONS AND WENT INTO HEMORRHAGIC SHOCK THE MORNING AFTER HER INITIAL SURGERY. AND SHE WAS TAKEN EMERGENTLY FOR AN EXPLORATORY LAPAROTOMY AND WAS FOUND TO HAVE AN INJURY TO HER RIGHT EXTERNAL ILIAC ARTERY."
        }
      ],
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}