BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TSL

    MDR report key: 1932993 · Received December 10, 2010

    Report

    Report Number
    9617613-2010-00020
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    April 16, 2008
    Report Date
    November 19, 2010
    Manufacturer
    TISSUE SCIENCE LABORATORI
    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 FOR STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT ALLEGEDLY EXPERIENCED PAIN AND SUFFERING AND HAS UNDERGONE OR WILL UNDERGO REVISIONARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TSL PELVISOFT BIOMESH SUPPORT SYSTEM FTL TISSUE SCIENCE LABORATORI UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R