BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TSL

    MDR report key: 1915749 · Received November 29, 2010

    Report

    Report Number
    9617613-2010-00016
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    June 12, 2002
    Report Date
    August 21, 2018
    Manufacturer
    TISSUE SCIENCE LABORATORIES, PLC
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT UNDERWENT A PELVICOL SLING REPAIR FOR TREATMENT OF URINARY STRESS INCONTINENCE. 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 SLING FTL TISSUE SCIENCE LABORATORIES, PLC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 DA Female Required Intervention| O