BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK DERMA HOOK

    MDR report key: 2093392 · Received April 19, 2011

    Report

    Report Number
    3003898360-2011-00232
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 15, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WILL BE RETURNED FOR INVESTIGATION. INVESTIGATION IS INCOMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A BRAIN SURGERY, ONE OF THE DEVICES BROKE LOOSE ALMOST CAUSING THE SCALP FLAP TO CLOSE OVER THE BRAIN TISSUE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK DERMA HOOK DERMA HOOK GDG TELEFLEX MEDICAL NA 01H1000446

    Patients

    Seq Age Sex Outcome Treatment
    1