BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON PROLENE SOFT PRO MESH

    MDR report key: 2910253 · Received January 9, 2013

    Report

    Report Number
    MW5028508
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    February 27, 2012
    Report Date
    January 9, 2013
    Manufacturer
    ETHICON
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD SURGERY ON (B)(6) 2012 FOR INGUINAL HERNIA REPAIR, WHERE SHE WAS IMPLANTED WITH MESH. IMMEDIATELY AFTER SURGERY, SHE EXPERIENCED HORRIFIC PAIN. PT STATES "IT FELT LIKE I HAD BEEN SHOT". PT HAD TO TRAVEL TO (B)(6) TO SEEK A PHYSICIAN. NO ONE ELSE WOULD TAKE HER. PT HAD REVISION SURGERY ON (B)(6) 2012, SURGEON FOUND PLASTIC PIECE FROM MESH MIGRATED UNDER HER HIP BONE WAS POKING HER BLADDER. SURGEON ALSO STATES THAT PT HAD A LOT OF SCAR TISSUE, AND TISSUE EROSION AROUND HER GROIN. PT STILL HAS SOME OF THE MESH IN HER THAT COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12601 ETHICON PROLENE SOFT PRO MESH MESH FTL ETHICON DGB215

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention