BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL MESH

    MDR report key: 1230111 · Received November 4, 2008

    Report

    Report Number
    MW5008974
    Event Type
    Other
    Date Received
    November 4, 2008
    Report Date
    November 4, 2008
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I HAD MY FIRST OPERATION IN 2005, BUT WITHIN A FEW MOS MY BLADDER HAD FALLEN AND I HAD ANOTHER OPERATION IN APPROX SIX MONTHS LATER AND ANOTHER MESH WAS USED. AFTER THIS OPERATION, I NEVER HEALED AND THERE WAS CONSTANT PAIN AND DRAINAGE THAT NEVER GOT BETTER. MY DAUGHTER LOCATED AN EXCELLENT DOCTOR AT THE MEDICAL CENTER FOR A SECOND OPINION. HE OPERATED IN 2006 TO TRY TO FIX THE PROBLEM, BUT BECAUSE OF SEVERE INFECTION THAT HAD CREATED CANALS AND SCAR TISSUE, HE HAD TO COMPLETELY REMOVE THE MESH. IN 2007 I HAD THE FOURTH OPERATION TO INSTALL ANOTHER MESH, WHICH WAS DONE SURGICALLY BECAUSE OF MY PRIOR PROBLEMS. I AM STILL UNDER HIS CARE BECAUSE OF SOME PAIN AND FOR INCONTINENCE. I AM ALSO AWARE OF TWO OTHER WOMEN WHO WERE OPERATED ON FOR THIS SAME PROBLEM IN WHICH THEY HAD A MESH USED AND ENDED UP WITH NUMEROUS PROBLEMS BEFORE GOING TO ANOTHER DOCTOR. IF I CAN ANSWER ANY FURTHER QUESTIONS, I WOULD BE GLAD TO, AND IF NEEDED SUPPLY YOU THE NAMES OF MY DOCTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL MESH NONE FTL

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR