BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLIGEN MARTRIX 4X7CM

    MDR report key: 3019270 · Received March 18, 2013

    Report

    Report Number
    9617613-2013-00106
    Event Type
    Injury
    Date Received
    March 18, 2013
    Date of Event
    May 13, 2011
    Report Date
    February 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. MONARC HAMMOCK SUBFASCIAL WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112780 PELVICOL ACELLULAR COLLIGEN MARTRIX 4X7CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC 10B03-9

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other