BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TSL

    MDR report key: 1910470 · Received November 24, 2010

    Report

    Report Number
    9617613-2010-00018
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 12, 2007
    Report Date
    October 28, 2010
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT AN UROLOGICAL REPAIR FOR TREATMENT OF STRESS URINARY INCONTINENCE. ALLEGEDLY, THE PT EXPERIENCED DAMAGE TO AN ORGAN SYSTEM AND PAIN. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK TSL PELVISOFT BIOMESH FTL TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R