BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRA ARTIFICIAL SKIN

    MDR report key: 142079 · Received January 9, 1998

    Report

    Report Number
    1121308-1997-00002
    Event Type
    Death
    Date Received
    January 9, 1998
    Date of Event
    December 1, 1997
    Report Date
    December 11, 1997
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPIRED AFTER RESUSCITATION ATTEMPTS FOR ASYSTOLE FAILED. PT HAD SEPSIS FOLLOWING BURNS TO 41% TOTAL BODY SURFACE AREA WITH SEVERE INHALATION INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA ARTIFICIAL SKIN Implant BILAYER MEMBRANE FOR SKIN REPLACEMENT MDD INTEGRA LIFESCIENCES CORP. NI 66025

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death NUMEROUS ANTIBIOTICS, ALLODERM (LEFT HAND)| (11/24/1997 TO NI)