BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER COMPLETE

    MDR report key: 2844235 · Received November 8, 2012

    Report

    Report Number
    1526350-2012-00282
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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 SKIN GRAFT MESHER'S GRAFTS WERE NOT EQUAL IN THICKNESS. DESPITE MULTIPLE F/U ATTEMPTS WITH THE CUSTOMER, NO ADDITIONAL INFO WAS ABLE TO BE OBTAINED REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER SKIN GRAFT MESHER COMPLETE ZIMMER SKIN GRAFT MESHER COMPLETE FZW ZIMMER SURGICAL NA 03942

    Patients

    Seq Age Sex Outcome Treatment
    1