BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2-0 VICRYL CP-2

    MDR report key: 1263286 · Received December 4, 2008

    Report

    Report Number
    MW5009196
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Report Date
    November 26, 2008
    Manufacturer
    ETHICON
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON DESCRIBES THE PROBLEM IN LAST FIVE ORTHOPEDIC PTS THAT WERE DONE. HE HAS BROUGHT PTS BACK FOR I & D WHEN INCISION WAS OPENED, PUS DRAINAGE, APPEARANCE OF NECROSIS OF TISSUE LOCALIZED AT THE SUTURE LINE. THIS WAS DEEP AND SUBCUTANEOUS. THE SUTURE IS 2-0 VICRYL CP-2. ALL HAVE BEEN PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2-0 VICRYL CP-2 SUTURE GAM ETHICON AG2285
    2 2-0 VICRYL CP-2 SUTUTRE GAM ETHICON AE2612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other