BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVICOL ACELLULAR COLLAGEN MATRIX 4 X 7 CM

    MDR report key: 2971220 · Received February 6, 2013

    Report

    Report Number
    9617613-2013-00026
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 10, 2007
    Report Date
    January 11, 2013
    Manufacturer
    COVIDIEN, FORMERLY TISSUE
    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51544 PELVICOL ACELLULAR COLLAGEN MATRIX 4 X 7 CM PELVICOL MESH FTL COVIDIEN, FORMERLY TISSUE NA 06B23-2

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R