BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIR DERMATOME KIT

    MDR report key: 1910519 · Received November 19, 2010

    Report

    Report Number
    1526350-2010-00167
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 20, 2010
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GFD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 THE ZIMMER AIR DERMATOME WAS CUTTING THE SKIN TOO DEEP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR DERMATOME KIT AIR DERMATOME KIT GFD ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1