BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSS-318

    MDR report key: 479780 · Received July 1, 2003

    Report

    Report Number
    1219288-2003-00001
    Event Type
    Injury
    Date Received
    July 1, 2003
    Date of Event
    June 10, 2003
    Report Date
    June 28, 2003
    Manufacturer
    VERMONT MEDICAL, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED A SKIN IRRITATION AFTER 10 TAB ELECTRODES HAD BEEN APPLIED TO ARMS, LEGS AND CHEST. THE TABS WERE ON THE PATIENT FOR APPROXIMATELY 5 MINUTES, PINKNESS APPEARED ON EACH SITE EXCEPT FOR THE RIGHT ARM. THESE IRRITATION SPOTS WERE THE SIZE OF A SILVER DOLLAR. WITHIN 10 MINUTES THE PINK AREAS TURNED TO WELTS. ALSO, PATIENT HAD HIVES ON TRUNK - FRONT AND BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSS-318 EKG TAB ELECTRODES DRX VERMONT MEDICAL, INC. PSS-318 56399

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other