BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAC FREEDOM PUMP

    MDR report key: 758450 · Received June 15, 2006

    Report

    Report Number
    MW1040325
    Event Type
    Injury
    Date Received
    June 15, 2006
    Date of Event
    November 3, 2005
    Report Date
    June 15, 2006
    Manufacturer
    *
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER A TVT BLADDER REPAIR SURGERY IN 2003, DEVLOPED A FISTULA THAT WAS REMOVED IN 2005. A MONTH LATER, HOOKED UP TO A VAC FREEDOM HCPC CODE E2402 RR, SET ON 100. TWO DAYS LATER ADMITTED BECAUSE OF PERFORATED COLON AND COLOSTOMY DONE. REVERSE COLOSTOMY DONE TWO MOS LATER. I WAS TOLD THE PERFORATION WAS CAUSED BY THE MESH - GYNECARE 810041, LOT #1323258. I'D LIKE TO KNOW THE ODDS OF WHETHER THAT MESH, THE VAC OR THE COMBINATION COULD HAVE CAUSED THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAC FREEDOM PUMP VAC GCY * HCPC *
    2 GYNECARE TVT IMPLANT MESH FTL * 810041 1323258

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O| S