BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOHNSON & JOHNSON ETHICON

    MDR report key: 1953601 · Received January 5, 2011

    Report

    Report Number
    MW5018885
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 4, 2011
    Manufacturer
    JOHNSON & JOHNSON ETHICON
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    J & J ETHICON 0 VICRYL ON UR-6 NEEDLE WAS PULLED THRU FASCIA BY SURGEON, THEN TIP OF NEEDLE BROKE OFF. NEEDLE WAS NOT IN PT WHEN BROKEN, TIP REMAINED IN NEEDLE HOLDER, NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON & JOHNSON ETHICON UR-6 NEEDLE FMI JOHNSON & JOHNSON ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR