BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME

    MDR report key: 3121791 · Received May 15, 2013

    Report

    Report Number
    3004608878-2013-00095
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 15, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE DERMATOME'S SCREWS WERE LOOSE DURING THE SURGERY. THE GRAFT WAS TOO THICK AND THE PT NEEDED SUTURES. ANOTHER DERMATOME WAS AVAILABLE. IT WAS UNK IF THE EVENT LEAD TO A SIGNIFICANT INCREASE IN SURGERY TIME." ADD'L INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214848 PADGETT MODEL S SLIMLINE ELECTRIC DERMATOME SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention