BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEXCARE TEGADERM TRANSPARENT DRESSING

    MDR report key: 805980 · Received January 10, 2007

    Report

    Report Number
    2110898-2007-00001
    Event Type
    Death
    Date Received
    January 10, 2007
    Date of Event
    November 10, 2005
    Report Date
    December 13, 2006
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION HAS BEEN REQUESTED AND IS PENDING. A CITIZEN'S PETITION WAS SUBMITTED TO THE FDA BY MYLAN PHARMACEUTICALS, INC. TO REQUEST APPLICANTS OF FENTANYL TRANSDERMAL PATCHES CONDUCT A STUDY TO SUPPORT THE SAFE USE OF AN OVERLAY WITH THEIR RESPECTIVE FENTANYL TRANSDERMAL PATCHES.

    Description of Event or Problem · 1

    3M REC'D A LAWSUIT FROM A LAW FIRM. THE LAWSUIT CLAIMS THAT A WOMAN WAS USING A FENTANYL TRANSDERMAL PATCH COVERED BY A 3M TEGADERM TRANSPARENT DRESSING AND THE WOMAN DIED AS A RESULT OF FENTANYL INTOXICATION. THE LAWSUIT CLAIMS THAT A HEALTH CARE PROVIDER ADVISED AND INSTRUCTED THE DECENDENT IN 2005 TO USE TEGADERM AS AN OVERDRESSING TO COVER AND HOLD THE FENTANYL PATCH IN PLACE BECAUSE THE DECEDENT WAS HAVING ADHESION PROBLEMS WITH THE FENTANYL PATCH. THE COMPLAINT ALLEGES THAT THE 3M DRESSING CREATED LOCALIZED HEAT AND CAUSED RAISED TEMPERATURE-INDUCED DELIVERY OF FENTANYL WHICH CAUSED HER DEATH IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXCARE TEGADERM TRANSPARENT DRESSING TRANSPARENT DRESSING FRO 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death MYLAN PHARMACEUTICALS, INC. FENTANYL TRANSDERMAL| SYSTEM 75 MCG/HR PATCH.