BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP TRANSOBTUR2 KIT X1

    MDR report key: 2356110 · Received November 28, 2011

    Report

    Report Number
    9615742-2011-00142
    Event Type
    Injury
    Date Received
    November 28, 2011
    Report Date
    October 24, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K041176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF#: 9617613-2011-00074 (PELVISOFT), 961742-2011-00141 (URETEX T02). NOTE: THIS REPORT CORRESPONDS WITH BARD'S REPORT # (B)(4) FOR A "URETEX."

    Description of Event or Problem · 1

    PROCEDURE TYPE: GYNECOLOGICAL/UROLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT TREATMENT FOR PELVIC ORGAN PROLAPSE, STRESS URINARY INCONTINENCE AND OTHER SYMPTOMS. ALLEGEDLY, THE PT EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE CORRECTIVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEX SUPPORT PP TRANSOBTUR2 KIT X1 URETEX TO2 FTL SOFRADIM PRODUCTION SFI00075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R