BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 3880265 · Received June 17, 2014

    Report

    Report Number
    MW5036642
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    January 1, 1997
    Report Date
    June 17, 2014
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT SHE HAD A MESH IMPLANTED IN 1997 DUE TO INCONTINENCE AND OVER ACTIVE BLADDER. SHE STATED THAT SHE BEGAN HAVING ABDOMINAL CRAMPS AND THE IMPLANT EVENTUALLY STOPPED WORKING CAUSING HER TO HAVE RECURRENT INCONTINENCE. SHE REPORTED THAT SHE WAS EITHER IMPLANTED WITH A NEW MESH OR THAT HER OLD MESH WAS REVISED IN 1998. IN 2003, SHE STATED THAT SHE HAD A HYSTERECTOMY. PT REPORTED THAT IN 2011, SHE HAD TO HAVE A STIMULATOR IMPLANTED DUE TO CONTINUED ISSUES WITH INCONTINENCE. IN 2013, SHE HAD THE STIMULATOR REMOVED BECAUSE, AS SHE STATED, IT DID NOT WORK. PT ALLEGES THAT HER PHYSICIAN CURRENTLY RECOMMENDED SHE HAVE AN ADD'L SURGERY BUT ALSO HAS ALSO STATED THAT SHE HAS A 50/50 CHANCE THAT HER BLADDER WILL BE PARALYZED IF SHE DOES SO. SHE REPORTED THAT SHE DOES NOT KNOW IF SHE SHOULD GO THROUGH WITH THIS SURGERY AND THAT SHE IS EMBARRASSED TO HAVE CONTINUED INCONTINENCE AT THIS STAGE IN HER LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355207 MESH MESH FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention