BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    MDR report key: 1971686 · Received January 19, 2011

    Report

    Report Number
    9615742-2011-00005
    Event Type
    Other
    Date Received
    January 19, 2011
    Report Date
    December 20, 2010
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT PT HAS SUFFERED PERSISTENT URINARY INCONTINENCE, PELVIC PAIN, BLADDER INFECTIONS, EROSION OF HER BLADDER, AND HAS UNDERGONE THREE SEPARATE PROCEDURES TO REMOVE THE ERODING MESH AND REPAIR THE DAMAGE DONE TO THE BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR FTL SOFRADIM PRODUCTION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention ALIGN S URETHRAL SUPPORT SYSTEM (B)(6) 2008