BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 2855918 · Received November 20, 2012

    Report

    Report Number
    3004608878-2012-00221
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER NOTED THE DERMATOME S "BLADE SHIMMIES OFF OF THE HOLDING PIN, SET SCREW LOOSENS TO THE SIDE OF UNIT." ON (B)(6) 2012 THE BIOMED STATED THAT THIS WAS DISCOVERED PRIOR TO USE ON A PT, NO PT INVOLVEMENT, INJURY OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADGETT MODEL S SLIMLINE ELECTRIC DERMATOME NONE GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1