BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECOLOGY CAPITAL

    MDR report key: 2217532 · Received August 19, 2011

    Report

    Report Number
    1643264-2011-00017
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 29, 2010
    Report Date
    July 22, 2011
    Manufacturer
    OKLAHOMA CITY MANUFACTURING SITE
    Product Code
    HIG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    BLEEDING POST OP, HEMOPERITONEUM, AND UTERINE PERFORATION, PATIENT STABLE UPON D/C TO (B)(6). DEVICE USAGE PROBLEM. THE DEVICE DID NOT WHAT IT WAS SUPPOSE TO DO. IT WAS REPORTED 7 MONTHS LATER AND SHE STATED THAT SHE IS BEHIND ON HER PAPERWORK AND IS STILL WORKING ON 2010 PAPERWORK. PHONE CONVERSATION WITH (B)(6) (RISK MGR) ON (B)(6) 2011 CLARIFIED THE EVENT: THE PART NUMBER IS 7210164 (FLUID MGMT SYS); THE PUMP INFUSED A LARGE DEFICIT OF FLUID CALCULATION (UNK EXACT AMOUNT) INTO THE PATIENT'S ABDOMEN WHICH SUBSEQUENTLY CAUSED FLUID TO ENTER THE LUNGS RESULTING IN PULMONARY EDEMA. NO OTHER INFORMATION ON PATIENT OR POST-OP STATUS WAS IN THE OPERATIVE NOTES. (B)(6) ALSO INDICATED THAT THE PERFORATION, WHICH WAS LESS THAN .5CM IN SIZE, WAS NOT CAUSED BY A S&N DEVICE AS THE SURGEON USED ANOTHER MANUFACTURER'S DEVICE TO REMOVE THE FIBROID. IT WAS SUGGESTED THAT (B)(6) COMPLETE A SUPPLEMENTAL REPORT TO CORRECT THE PREVIOUSLY REPORTED EVENT DESCRIPTION AND FORWARD A COPY TO S&N AS WELL AS THE FDA. (DL) LOT # PROVIDED DOES NOT SHOW UP IN DATABASE AS BEING SOLD TO THIS CUSTOMER; THEREFORE NO DATE OF DEVICE MANUFACTURE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECOLOGY CAPITAL CU, HYSTER, FLUID MGMT SYSTEM HIG OKLAHOMA CITY MANUFACTURING SITE 7210164 101CM402

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR