BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 508906 · Received January 21, 2004

    Report

    Report Number
    MW1030920
    Event Type
    Malfunction
    Date Received
    January 21, 2004
    Date of Event
    December 16, 2003
    Report Date
    January 21, 2004
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ZIMMER AIR DERMATOME USED TO ATTEMPT RETRIEVAL OF FIRST SKIN GRAFT. EQUIPMENT DESTROYED DONOR TISSUE RENDERING IT USELESS FOR GRAFTING. EQUIPMENT WAS REMOVED FROM SERVICE AND ANOTHER DERMATOME WAS BROUGHT IN TO HARVEST TISSUE. OUTCOME FOR PT-SLIGHTLY LARGER DONOR SITE SCAR. NOTE: PREVIOUS EQUIPMENT PROBLEM 9/2003, NOT REMOVED FROM SERVICE UNTIL 12/2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER AIR DERMATOME GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS 8801-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other