BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE MONITORING ELECTRODE

    MDR report key: 33724 · Received June 26, 1996

    Report

    Report Number
    MW1009377
    Event Type
    Other
    Date Received
    June 26, 1996
    Date of Event
    May 3, 1996
    Report Date
    June 5, 1996
    Manufacturer
    VERMONT MEDICAL, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    4 1/2-YEAR-OLD FEMALE UNDERWENT CARDIAC CATH ON 5/3/96. ON 5/5/96 HER MOTHER REPORTED SIGNIFICANT BURNS AND SKIN BREAKDOWN AT ALL ELECTRODE PATCH SITES. THESE WERE TREATED WITH BACITRACIN, CORTISONE CREAM AND VITAMIN E CREAM AND ARE HEALING WELL BUT MAY RESULT IN SCARS. MFR WAS CONTACTED AND STATED THAT ELECTRODES WERE FOR USE ON ADULTS ONLY. THERE IS NO INDICATION ON THE PACKAGING. EXPIRATION DATE 5/8/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MONITORING ELECTRODE DISPOSABLE MONITORING ELECTRODE DRX VERMONT MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other