BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 1915255 · Received November 2, 2010

    Report

    Report Number
    1526350-2010-00157
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER AIR DERMATOME WAS TEARING THE SKIN IN THE CENTER OF THE GRAFT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1