BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON

    MDR report key: 2982696 · Received February 21, 2013

    Report

    Report Number
    MW5029151
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SUTURING OF VAGINAL GRAFT, USING A VICRYL J417 THE NEEDLE FROM THE SUTURE BROKE IN HALF. THE DOCTOR ATTEMPTED TO FIND THE BROKEN END OF THE NEEDLE IN VAGINAL VAULT UNSUCCESSFULLY. PELVIC XRAY DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77472 ETHICON VICRYL GAM ETHICON J417

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR