BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM

    MDR report key: 2930431 · Received January 3, 2013

    Report

    Report Number
    9617613-2012-00282
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 20, 2006
    Report Date
    December 5, 2017
    Manufacturer
    COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES
    Product Code
    FTL
    PMA / PMN Number
    K992556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFO FROM IMPORTER REPORT: COMMON DEVICE NAME: FTL; (B)(4). (B)(6).

    Description of Event or Problem · 1

    PROCEDURE: UROLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. BARD DERMAL ALLOGRAFT WAS REPORTED TO BE USED/IMPLANTED DURING THE SAME PROCEDURE. ADDITIONAL INFO FROM IMPORTER REPORT: ADDITIONAL INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR: 1018233-2012-02085.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3600 PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES NA 06B16-1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other BARD DERMAL ALLOGRAFT| BARD DERMAL ALLOGRAFT