BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRA DERMAL REGENERATION TEMPLATE 4X10

    MDR report key: 525082 · Received May 14, 2004

    Report

    Report Number
    1121308-2004-00012
    Event Type
    Death
    Date Received
    May 14, 2004
    Report Date
    May 14, 2004
    Manufacturer
    INTEGRA LIFESCIENCES CORP.
    Product Code
    MDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IS NOT EXPECTED TO BE RETURNED. THE DISTRIBUTOR SOLD THE PRODUCT TO HOSP. THE HOSP RPEORTED USE OF 15 PATCHES OF THE SKIN ON A PATIENT. THE PATIENT EXPIRED. THE PHYSICIAN HAS ASKED THAT SOMEONE FROM INTEGRA COME AND CONDUCT TRAINING ON THE USE OF INTEGRA ARTIFICIAL SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA DERMAL REGENERATION TEMPLATE 4X10 INTEGRA ARTIFICAL SKIN MDD INTEGRA LIFESCIENCES CORP. * 3604310Z

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death