BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REACT DX

    MDR report key: 21256485 · Received January 28, 2025

    Report

    Report Number
    MW5165356
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    January 18, 2025
    Report Date
    January 22, 2025
    Manufacturer
    MEDICOMP, INC.
    Product Code
    MLO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT STATES SHE WAS WEARING REACT DX CARDIAC MONITOR AND STATES SHE FELT A BURNING AND SEVERE ITCH. SHE STATES THAT BATTERY APPEARED CORRODED AND SHE CONTINUES TO FEEL PAIN AND HAS AN OBVIOUS SCABBED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502018 REACT DX ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM MLO MEDICOMP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other