BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI HEART MONITOR

    MDR report key: 18092403 · Received November 7, 2023

    Report

    Report Number
    MW5147890
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 7, 2023
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT AN ADVERSE EVENT INVOLVING HER BOSTON SCIENTIFIC MINI HEART MONITOR. PATIENT STATED AFTER ABOUT 2 WEEKS OF USE, SHE STARTED ITCHING UNDER THE PAD. PATIENT STATED SHE CALLED THE MANUFACTURER AND WAS SENT ANOTHER PAD THAT WAS HYPOALLERGENIC. SHE SAID WHEN SHE REMOVED THE OLD PAD TO PUT ON THE NEW PAD, SHE NOTICED DRIED BLOOD AROUND THE PATCH. PATIENT SAID SHE CONTACTED THE MANUFACTURER AND WAS TOLD SHE WOULD RECEIVE A CALL BACK AND THAT SHE WAITED 3 DAYS AND NEVER HEARD FROM ANYONE. PATIENT SAID SHE DECIDED TO TAKE OFF THE MONITOR HERSELF BECAUSE OF THE IRRITATION AND FOUND BLEEDING SORES UNDER THE PATCH WITH BLOOD AROUND THE EDGES. PATIENT SAID HER SKIN WAS RAW AND RED. REFERENCE REPORT MW5147889.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104132 MINI HEART MONITOR DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female