BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENESSA

    MDR report key: 997136 · Received February 6, 2008

    Report

    Report Number
    MW5005340
    Event Type
    Injury
    Date Received
    February 6, 2008
    Date of Event
    September 17, 2007
    Report Date
    February 6, 2008
    Manufacturer
    NOVASYS MEDICAL, INC.
    Product Code
    NVJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD RENESSA DONE, AND IT HAS MADE MY INCONTINENCE FROM BAD TO WORSE, EVEN AFTER HAVING BLADDER REPAIR "SLING". IT HAS STAYED BAD, AND HASN'T IMPROVED. I BELIEVE THAT RENESSA HAS RUINED MY WAY OF LIFE, AND HAS CREATED MANY PROBLEMS. AM I THE ONLY ONE THAT HAS COMPLAINED, OR ARE THERE OTHERS. RENESSA CLAIMS IT IS THE DR'S PROBLEM, BECAUSE OF THEIR DISCLAIMERS TO THEM. THE DR HAS ME TAKING DETROL-LA, AND SO FAR, NO RELIEF AFTER TWO WEEKS WHAT RECOURSE DO WE HAVE, IF ANY?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENESSA NONE NVJ NOVASYS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Disability