BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2132224 · Received June 14, 2011

    Report

    Report Number
    9615742-2011-00055
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    July 19, 2006
    Report Date
    May 11, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 9615742-2011-00054 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM), 9615742-2011-00053 (AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A POSTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE AND STRESS URINARY INCONTINENCE. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PATIENT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX SUPPORT SYSTEM FTL SOFRADIM PRODUCTION SGE00121

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other| R