BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL SUTURE 3-0, 27"

    MDR report key: 3913646 · Received June 27, 2014

    Report

    Report Number
    MW5037047
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ETHICON INC J&J
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE BROKE IN THE PATIENT ON THE FIRST STITCH. BOTH REMNANTS WERE RECOVERED. AN X-RAY ORDERED AND WAS CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376445 MONOCRYL SUTURE 3-0, 27" SUTURE NEEDLE GAM ETHICON INC J&J GL6694

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR