BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TSL

    MDR report key: 1915751 · Received November 29, 2010

    Report

    Report Number
    9617613-2010-00015
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    May 1, 2005
    Report Date
    October 29, 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 PATIENT UNDERWENT A UROLOGICAL REPAIR PROCEDURE FOR TREATMENT OF URINARY STRESS INCONTINENCE AND PELVIC ORGAN PROLAPSE. ALLEGEDLY, THE PATIENT EXPERIENCED DAMAGE TO AN ORGAN SYSTEM AND PAIN. PATIENT 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 UNKNOWN TSL PELVICOL FTL TISSUE SCIENCE LABORATORIES PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R