BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOCLUSIVE OCCLUSIVE FILM DRESSING

    MDR report key: 566096 · Received January 4, 2005

    Report

    Report Number
    MW1034329
    Event Type
    Other
    Date Received
    January 4, 2005
    Date of Event
    December 6, 2004
    Report Date
    January 3, 2005
    Manufacturer
    JOHNSON & JOHNSON ETHICON
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT HAS REACTION TO BIOCLUSIVE AT TWO SITES, RIGHT HIP AND LEFT FOREARM DEVELOPED BLISTERS AT APPLICATION SITE WITIN 6-8 HOURS AFTER APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCLUSIVE OCCLUSIVE FILM DRESSING * MGQ JOHNSON & JOHNSON ETHICON * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other ALLEGRA| PROTONIX| SENNA| MULTI-VITS| KLONOPIN| PERSANTINE| DEPAKOTE| BACLOFEN| OMS| ESTRAM TX| VIT-C| DSS 100MG BID| DOXEPIN