BEUDAMED
    FDA Adverse Event Other Summary report: N

    ETHICON, INC

    MDR report key: 2750726 · Received October 8, 2008

    Report

    Report Number
    2750726
    Event Type
    Other
    Date Received
    October 8, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ETHICON, INC
    Product Code
    GAM
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SUTURE NEEDLE BROKE AS LAST STITCH WAS PULLED THROUGH THE FASCIA. BROKEN PIECES WERE PLACED ON NEEDLE HOLDER MAGNET AND DISPOSED OF. SUTURE NEEDLE PIECES DID NOT FALL INTO PT. NO PT HARM. SUTURES WITH THE SAME LOT NUMBER REMOVED FROM OPERATING ROOM. NO CHANGE IN TYPE OF NEEDLE DRIVER USED. ONLY OTHER SUTURE WITH SAME LOT NUMBER AVAILABLE. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC 0 PDS PLUS ANTIBACTERIAL GAM ETHICON, INC AD6416

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR