BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRA ARTIFICIAL SKIN

    MDR report key: 285257 · Received July 12, 2000

    Report

    Report Number
    1121308-2000-00008
    Event Type
    Death
    Date Received
    July 12, 2000
    Report Date
    July 12, 2000
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    MDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CASE HISTORY WAS REPORTED VIA DRAFT OF MANUSCRIPT OUTLINING A BURN SCAR REVISION PROCEDURE USING ARTIFICIAL SKIN PRODUCT. PT WAS DISCHARGED TO HOME WITH ORAL ANTIBIOTICS ON THE FIFTH POST-OPERATIVE DAY. PT WAS RE-ADMITTED TO HOSP ON NINTH POST-OPERATIVE DAY WITH FEVER AND NAUSEA. SITE OF ARTIFICAL SKIN PLACEMENT SHOWED NO SIGNS OF PUS. ARTIFICIAL SKIN WAS EXCISED, AND COMPLETE DEBRIDEMENT OF THE WOUND AREA WAS UNDERTAKEN AFTER INTUBATION AND VENTILATION OF THE PT. NO VISIBLE SIGNS OF INFECTION WERE NOTED. PT SUCCUMBED TO POST-SURGICAL CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE MDD INTEGRA LIFESCIENCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death 0.5% SILVER NITRATE SOLUTION (UNK TO UNK) (STOP'D