BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA ARTIFICIAL SKIN

    MDR report key: 234926 · Received August 6, 1999

    Report

    Report Number
    1121308-1999-00003
    Event Type
    Injury
    Date Received
    August 6, 1999
    Date of Event
    February 13, 1999
    Report Date
    August 6, 1999
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MGR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOSS OF DERMAL AUTOGRAFT. BURN INJURY DATE WAS 02/13/1999. INTEGRA PLACED ON INJURY SITE ON 02/18/1999. SILICONE LAYER OF INTEGRA REMOVED ON 03/09/1999. NEODERMIS NOTED AS NORMAL. EPIDERMAL AUTOGRAFT PLACED ON WOUND SITES ON 03/09/1999 AFTER PARTIAL DEBRIDEMENT OF SITES. LOSS OF AUTOGRAFT NOTED AT 77% ON RIGHT THIGH, 50% ON LEFT THIGH AND LEG. SIGNS AND SYMPTOMS OF INFECTION WERE NOTED AND TREATED TOPICALLY WITH SULFAMYLON SOLUTION. REGRAFTING WAS PERFORMED ON 03/31/1999, EVENT RESOLVED ON 04/07/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA ARTIFICIAL SKIN Implant DERMAL REGENERATION TEMPLATE MGR INTEGRA LIFESCIENCES CORP. 8 X 10 8601400

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization ANCEF (1999 TO 1999 (STOP'D)).