BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON

    MDR report key: 751845 · Received August 11, 2005

    Report

    Report Number
    MW1036320
    Event Type
    Other
    Date Received
    August 11, 2005
    Date of Event
    January 1, 2005
    Report Date
    August 11, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I HAVE NOTICED SEVERAL LOCALIZED INFLAMMATORY REACTIONS TO GREEN MONOFILAMENT SUTURE MATERIAL, ETHICON -JOHNSON & JOHNSON PRODUCT. EVENTS ARE SPORADIC AND OCCURRED THROUGHOUT 2004 AND 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON 5-0 ETHILON, PS-2 GREEN MONOFILAMENT NYLON SUTURE GAO ETHICON, INC. * SBJ098

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other