BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE

    MDR report key: 2171496 · Received July 20, 2011

    Report

    Report Number
    2171496
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SUTURE PULLING AWAY FROM THE NEEDLE. THIS HAPPENED TO SEVERAL PACKS OF SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLENE SUTURE, NON-ABSORBABLE GAT ETHICON, INC. 8665G DDB404

    Patients

    Seq Age Sex Outcome Treatment
    1 *