BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMATOME

    MDR report key: 917828 · Received September 13, 2007

    Report

    Report Number
    MW5003813
    Event Type
    Injury
    Date Received
    September 13, 2007
    Date of Event
    September 18, 2007
    Manufacturer
    ZIMMER INC
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THREE TOTAL DERMATOMES USED DURING SKIN GRAFT PROCEDURE. FIRST DERMATOME - # INS 0000139-001- WAS NOT EFFECTIVE IN HARVESTING ENOUGH TISSUE. SECOND DERMATOME - # INS 0000139-002- SKIPPED WHILE IN USE. THIRD DERMATOME EFFECTIVE AT CREATING GRAFT TISSUE. EXPECT THIS PT WILL HAVE LARGER, PERMANENT SCAR THAN WOULD OTHERWISE HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DERMATOME DERMATOME GFD ZIMMER INC INS 0000139-001 *
    2 DERMATOME DERMATOME GFD ZIMMER, INC INS 0000139-002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention