BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER MESH IMPLANT

    MDR report key: 2520931 · Received April 5, 2012

    Report

    Report Number
    MW5024881
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    November 29, 2010
    Report Date
    April 5, 2012
    Manufacturer
    NA
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED TO REPORT ON A MESH IMPLANT SHE HAD IMPLANTED IN HER BLADDER ON (B)(6) 2010. SHE STATED THE IMPLANT DID NOT DO THE JOB AND FELL OUT TWICE. PT STATED SHE HAD A HYSTERECTOMY ON (B)(6) 2010, WHICH IS WHEN THE MESH WAS IMPLANTED. THREE MONTHS LATER, THE PT STATED THE IMPLANT FELL OUT. SHE SAID SHE WAS HOSPITALIZED IN (B)(6) 2011 AND HAD THE MESH RE-DONE. SHE DECIDED TO HAVE THE MESH IMPLANT TAKEN OUT ON (B)(6) 2012, SINCE IT WAS NOT WORKING AND FELL OUT TWICE. SHE DID NOT EXPERIENCE ANY PAIN, BUT WAS UNHAPPY WITH THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADDER MESH IMPLANT BLDDER MESH IMPLANT FTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR