BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME

    MDR report key: 3891242 · Received June 24, 2014

    Report

    Report Number
    3891242
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 12, 2014
    Manufacturer
    INTEGRA: 311 ENTERPRISE DR.
    Product Code
    GFD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED NOTIFICATION ON (B)(6) 2014 FROM OPERATING ROOM THAT THE SURGEON WAS PERFORMING A SPLIT THICKNESS SKIN GRAFT. WHILE HARVESTING THE SKIN, IT WAS REPORTED THAT THE UNIT CUT OUT WHILE IN USE. THIS IS REPORTED THAT IT CAUSED A SKIPPED EFFECT ON THE PATIENT'S THIGH RENDERING THE HARVEST OF TISSUE NOT USEABLE. HARVEST SITE CLEANED. PROCEDURE NOT COMPLETED. PATIENT IS BEING SENT TO A SPECIALIST FOR THE SKIN GRAFT. POSSIBLY PROBLEMS FOR PATIENT IS LEAVING A PERMANENT SCAR. PATIENT IS A SLOW HEALER, SO PATIENT HAS THE POSSIBILITY OF INFECTION AND HARVEST SITE NOT HEALING OR SLOW TO HEAL. PATIENT DISCHARGED HOME WITH (B)(6) ON (B)(6) 2014. HAVE TALKED WITH (B)(4) AT INTEGRA AND OFFERED FOR THEM TO COME ON SITE TO INSPECT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367768 DERMATOME PADGETT DERMATOME INSTRUMENT GFD INTEGRA: 311 ENTERPRISE DR. MODEL B

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| S