BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EKG BACKPAD

    MDR report key: 32123 · Received January 31, 1996

    Report

    Report Number
    32123
    Event Type
    Malfunction
    Date Received
    January 31, 1996
    Date of Event
    August 11, 1995
    Report Date
    September 5, 1995
    Manufacturer
    NDM CORP.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN EKG PAD WAS REMOVED FROM THE PT'S BACK POST-OP, RED-PURPLE BLEMISHES PLUS ONE BLISTERED LESION ON SKIN ALONG EKG BACK PAD WIRING TRACT WERE NOTED. THESE AREAS COINCIDED WITH AREAS ON THE EKG PAD THAT WERE WRINKLED, OR SLIGHTLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EKG BACKPAD EKG PACKPAD DRX NDM CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR