BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON 0 PROLENE SUTURE

    MDR report key: 1930202 · Received December 9, 2010

    Report

    Report Number
    1930202
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    December 8, 2012
    Report Date
    December 8, 2010
    Manufacturer
    ETHICON
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TO SURGERY FOR SCHEDULED BILATERAL INGUINAL HERNIA REPAIR WITH MESH USING AN OPEN TECHNIQUE. SURGEON WAS USING ETHICON 0 PROLENE M06 NEEDLE. SURGEON FELT LIKE HE STRUCK HARD SURFACE, NEEDLE OFF OF SUTURE. X-RAY TAKEN, NOT ABLE TO LOCATE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON 0 PROLENE SUTURE ETHICON 0 PROLENE SUTURE GAW ETHICON CDR178

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other