BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL 2CM X 7CM 1.0MM

    MDR report key: 3001096 · Received March 5, 2013

    Report

    Report Number
    9617613-2013-00074
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 7, 2010
    Report Date
    February 7, 2013
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: PELVICOL ACELLULAR COLLAGEN MATRIX. MFR NAME AND ADDRESS: TISSUE SCIENCE LABORATORIES, (B)(4). (B)(6).

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94000 PELVICOL 2CM X 7CM 1.0MM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES NA 09B04-9

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R