BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATSON DERMATOME

    MDR report key: 8580698 · Received May 4, 2019

    Report

    Report Number
    8010099-2019-00006
    Event Type
    Malfunction
    Date Received
    May 4, 2019
    Report Date
    May 4, 2019
    Manufacturer
    MEDICON E.G.
    Product Code
    EMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE BAR WAS DEFORMED, CAUSING MISALIGNMENT OF THE BLADE AND RESULTING IN THE UNEVEN SPACE AND THE FAULTY "0" SETTING OBSERVED BY THE USER. THIS TYPE OF DEFORMATION AND MISALIGNMENT WOULD REQUIRE A STRONG IMPACT TO THE DEVICE, PERHAPS DUE TO IMPROPER TRANSPORT OR FALLING. PROBABLE CAUSE IDENTIFIED AS IMPROPER HANDLING, IN ADDITION TO LACK OF ROUTINE DEVICE INSPECTION BY USER PRIOR TO DEVICE REUSE.

    Description of Event or Problem · 1

    DURING SURGICAL USE, THE FOLLOWING DEVICE PROBLEMS WERE OBSERVED: EXISTENCE OF A SPACE EVEN WHEN THE DEVICE IS SET TO "0"; UNEVEN SPACE. IT WAS THEREFORE IMPOSSIBLE TO PRODUCE SKIN GRAFTS OF CONSISTENT THICKNESS ADEQUATE FOR TRANSPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373742 WATSON DERMATOME SKIN GRAFT KNIFE EMF MEDICON E.G. 797Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Other