BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 4143407 · Received September 8, 2014

    Report

    Report Number
    1526350-2014-00425
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THERE WAS A MALFUNCTION OF THE DEVICE WHERE IT WAS BELIEVED THE OPENING OF THE DEVICE WAS BENT. AN ALTERNATE DEVICE WAS OBTAINED TO COMPLETE THE SURGERY, HOWEVER THE SURGEON WAS REQUIRED TO PERFORM ADDITIONAL SUTURING DUE TO THE DAMAGE TO THE THIGH. THE ORIGINAL INTENDED PROCEDURE WAS WIDE LOCAL EXCISION OF SCALP VERTEX CARCINOMA IN SITU CREATING A DEFECT OF 6.5 X 7. THE SURGERY WAS DELAYED BETWEEN 16-30 MINUTES. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549738 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR