BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME HANDPIECE

    MDR report key: 3240429 · Received July 18, 2013

    Report

    Report Number
    1526350-2013-00389
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE ZIMMER AIR DERMATOME, THE BLADE POPPED OFF OF THE DEVICE AND GOUGED THE PATIENT. IT WAS REPORTED THAT THE DEVICE WAS DISCONNECTED AND THE SURGEON SUTURED THE GOUGE ON THE PATIENT. AN ALTERNATE DEVICE WAS RETRIEVED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30-45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335199 AIR DERMATOME HANDPIECE AIR DERMATOME HANDPIECE GFD ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention