BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TSL

    MDR report key: 2021560 · Received March 8, 2011

    Report

    Report Number
    9617613-2011-00006
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    December 19, 2006
    Report Date
    February 4, 2011
    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). MDR REF #: 9615742-2011-00020 (AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM); 9615742-2011-00021 (AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A POSTERIOR AND ANTERIOR REPAIR PROCEDURE FOR TREATMENT OF PELVIC ORGAN PROLAPSE. THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN TSL PELVISOFT FTL TISSUE SCIENCE LABORATORIES, PLC 06B03-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R