BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOF-WICK IV SPONGE

    MDR report key: 184212 · Received August 27, 1998

    Report

    Report Number
    1618732-1998-00190
    Event Type
    Other
    Date Received
    August 27, 1998
    Report Date
    July 31, 1998
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    EFQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS: A MALE PT DEVELOPED CONTACT DERMATITIS WHILE USING THE PRODUCT. THE GAUZE WAS USED OVER A PORT AFTER IT HAD BEEN ACCESSED AND WAS THEN COVERED WITH A COMPETITOR'S TRANSPARENT DRESSING. THE FIRST WEEK IT WAS USED THE PT EXPERIENCED IRRITATION UNDER THE DRESSING. THE CLINICIANS WERE UNABLE TO DETERMINE IF IT WAS CAUSED BY THE GAUZE OR THE TRANSPARENT DRESSING. THE SECOND WEEK THE PROBLEM INCREASED TO REDNESS. THE THIRD WEEK THE PT DEVELOPED CONTACT DERMATITIS. THE IRRITATED AREA SHADOWED THE GAUZE EXCLUDING THE SLIT. THE PT HAS BEEN PLACED ON KEFLEX 500 MG THREE TIMES DAILY. THE DRESSINGS WERE IN PLACE 7 DAYS AT A TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-WICK IV SPONGE SPONGE, GAUZE EFQ JOHNSON & JOHNSON MEDICAL, INC. NA 199801, OPR5729

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other PT WAS RECEIVING 5 FU AT THE SAME TIME.