BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 1081378 · Received July 11, 2008

    Report

    Report Number
    1081378
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    April 12, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE SUTURING, NEEDLE BROKE OFF OF SUTURE WHILE SUTURING PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON SUTURE GAO ETHICON, INC. * ZEM433
    2 * ---

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR
    2 35 YR