BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 2111053 · Received May 17, 2011

    Report

    Report Number
    3004608878-2011-00068
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 17, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS MFG BEFORE 1990 AND NOT ELIGIBLE FOR REPAIR. IT WAS LAST SERVICED IN 2006. IT IS EXPECTED FOR EVAL. TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE DERMATOME WAS NOT ACQUIRING THE SKIN PROPERLY. A NEW BLADE WAS LOADED ONTO THE HANDPIECE AND CONTINUED TO SHRED THE SKIN. A NEW HANDPIECE AND BLADE WAS USED WHICH OBTAINED A PROPER SKIN GRAFT. INTEGRA REQUESTED ADD'L CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL B 110 V ELECTRO DERMATOME COMPLETE KIT SKIN GRAFT PRODUCTS GFD INTEGRA, CINCINNATI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other