BEUDAMED
    FDA Adverse Event Other Summary report: N

    MESH

    MDR report key: 3983415 · Received August 4, 2014

    Report

    Report Number
    MW5037608
    Event Type
    Other
    Date Received
    August 4, 2014
    Date of Event
    May 1, 2005
    Report Date
    August 4, 2014
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS UNDERGOING A TRIPLE HERNIA REPAIR IN (B)(6) 2005. POST-SURGERY CALLER STATES SHE WENT TO A NURSING HOME AND DRAINAGE WAS FOUND FROM HER TUBING. CALLER STATES HER STITCHES WERE REMOVED AND SHE WAS DIAGNOSED WITH A STAPH INFECTION. IN 2009 CALLER STATES THAT AN ABSCESS WAS LOCATED IN HER LOWER ABDOMEN. CALLER REPORTS SHE WAS ADVISED THAT THE MESH WAS TO BE REMOVED BUT SHE DECLINED THE OPERATION AND IS CURRENTLY GETTING THE ABSCESS TREATED WITH BIWEEKLY CAUTERIZATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455334 MESH ABDOMINAL MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR