BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS HOLTER MONITOR

    MDR report key: 20269000 · Received September 19, 2024

    Report

    Report Number
    MW5159797
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 17, 2024
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED A PHILIPS HOLTER MONITOR AND AFTER USE I NOTICED I HAD BURNS ON MY SKIN. THEY STARTED OUT AS STINGING AREAS AND AFTER REMOVING THE MONITOR I COULD VISIBLY SEE THE DAMAGE. I HAD THE MONITOR ON FOR TWO WEEKS AND NOW I HAVE A SCAR ON THE CENTER OF MY CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309104 PHILIPS HOLTER MONITOR ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention ATENOLOL.