BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX HERNIA PATCH

    MDR report key: 2954103 · Received February 7, 2013

    Report

    Report Number
    MW5028890
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    June 1, 2008
    Report Date
    February 7, 2013
    Manufacturer
    C.R. BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ADVERSE EVENTS REGARDING THE VENTRALEX HERNIA PATCH. PT STATED SHE HAD THE PATCH IMPLANTED FOR HERNIA REPAIR IN (B)(6) 2008, AND SOON AFTER, SHE BEGAN HAVING SEVERE PAIN AND WOULD USE THE BATHROOM ABOUT 30 TIMES A DAY. SHE STATED SHE WAS DIAGNOSED WITH INTERSTITIAL CYSTITIS WHICH CAUSES HER SEVERE PAIN. SHE STATED SHE CAN'T SIT OR STAND FOR LONG PERIODS OF TIME AND FEELS LIKE THERE IS AN ABSCESS INSIDE OF HER. PT SAID SHE TAKES PAIN MEDICATIONS, BUT STILL EXPERIENCES A LOT OF PAIN. SHE STATED SHE WAKES UP IN BURNING PAIN AND HAS TROUBLE SLEEPING. SHE ALSO SAID HER BOWELS HAVE CHANGED. SHE SAID HER LIFE HAS BEEN AFFECTED AND SHE IS NOW DISABLED. SHE SAID SHE HAS PROBLEMS TAKING CARE OF HER 4 KIDS AND KEEPING UP WITH THEIR DAILY ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51445 VENTRALEX HERNIA PATCH HERNIA MESH FTL C.R. BARD HUSB0904

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Disability