BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME, UNK

    MDR report key: 2780362 · Received October 5, 2012

    Report

    Report Number
    3004608878-2012-00178
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORP. OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE DOCTOR STATED: "A PORTION OF THE SKIN (OF A CHILD) WAS TAKEN AND CONTAMINATED BY THE OIL/LUBRICANT LEAKAGE FROM (THE) PADGETT DERMATOME. THE SKIN PIECE WAS "LOST" AND HAD TO BE 'WASTED'. THERE WAS THE NEED FOR AND ADDITIONAL SKIN TRANSFER PROCEDURE." ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMATOME, UNK SKIN GRAFT PRODUCTS GFD INTEGRA LIFESCIENCES CORP. OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1