BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK RANEY CLIPS DISPOSABLE

    MDR report key: 2864494 · Received December 6, 2012

    Report

    Report Number
    3003898360-2012-00555
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 15, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN IF SAMPLE AVAILABLE FOR INVESTIGATION. NO LOT # WAS MADE AVAILABLE. COMPLAINT CANNOT BE CONFIRMED SINCE THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER, THE MANUFACTURER WILL CONTINUE TO TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE DEVICE SHATTERED DURING SURGERY. SOME FRAGMENTS MAY HAVE ENTERED THE INCISION. ONLY 2 OF 3 FRAGMENTS WERE RECOVERED. SURGEON CHOSE TO CLOSE UP NOT KNOWING IF ONE OF THE FRAGMENTS WAS RETAINED. PATIENT'S CONDITION UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK RANEY CLIPS DISPOSABLE RANEY CLIPS FZP TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1