BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 3853971 · Received April 17, 2014

    Report

    Report Number
    1526350-2014-00290
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED ON 08/28/2007 AND HAS NO REPAIR HISTORY AT ZIMMER SURGICAL. UNABLE TO DETERMINE A CAUSE OF THE REPORTED EVENT AS THE DEVICE WAS NOT RETURNED TO THE ZIMMER SURGICAL FOR EVALUATION OR REPAIR.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER WAS MAKING THE SKIN STICK TOWARDS THE RIGHT WHEN MESHED. THERE WAS NO PT HARM OR DELAY IN SURGERY REPORTED, AND AN ALTERNATE DEVICE WAS NOT RECEIVED FOR USE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236148 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1