BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3-0 DEXON II

    MDR report key: 35230 · Received July 18, 1996

    Report

    Report Number
    35230
    Event Type
    Malfunction
    Date Received
    July 18, 1996
    Date of Event
    January 31, 1996
    Report Date
    February 6, 1996
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CLOSING OF OPERATIVE WOUND A NEEDLE BROKE AND BOTH HALVES WERE LOST IN THE FIELD. THE WOUND WAS EXPLORED AND NO NEEDLES FOUND. POST-OP X-RAY REVEALED 3/4 INCH PIECE OF NEEDLE. THE PT WAS REINTUBATED. THE UPPER SEVEN STAPLES WERE REMOVED AND USING C-ARM GUIDANCE THE NEEDLE WAS IDENTIFIED AND REMOVED. ALL PRODUCTS WITH THE SAME LOT # WERE REMOVED FROM STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3-0 DEXON II Implant ABSORBABLE SURGICAL SUTURES WITH D-TACH NEEDLE GAN DAVIS & GECK, INC. 932894

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other