BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOLTER MONITOR

    MDR report key: 16974662 · Received May 19, 2023

    Report

    Report Number
    MW5117741
    Event Type
    Injury
    Date Received
    May 19, 2023
    Date of Event
    May 16, 2023
    Report Date
    May 18, 2023
    Manufacturer
    TZ MEDICAL, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    13YR OLD CHILD WAS GIVEN TZ HOLTER MONITOR, PLACED AT (B)(6) HOSPITAL ON 5/15. WAS PLACED BY STAFF AND LEFT ON FOR 24 HRS AS REQUIRED. CHILD WORE AS DIRECTED. DID NOT SHOWER EVEN THOUGH IT WAS SUPPOSED TO BE OK. DID NOT PLAY SPORTS. MOSTLY LAID AROUND THE HOUSE WITH DEVICE ON. IT WAS NOT MISUSED, TAMPERED WITH, ETC. CAME TO US STATING THAT HER CHEST HURT AND WAS HOT. STATED IT WAS VERY HOT AT SOME POINT IN THE NIGHT. ONCE WE REMOVED DEVICE AND TX MEDICAL COMPANY SUPPLIED STICKER, WE FOUND SHE HAD SMALL 1ST DEG BURN TO CHEST WITH SOME SLIGHT BRUISING. THE DEVICE APPEARS TO HAVE SHORT CIRCUITED. PART OF PLASTIC HOLDER FOR DEVICE WAS MELTED. AGAIN, DIDN'T GET WET. NO LOTIONS OR PRODUCTS APPLIED. SHE HAD LOW ACTIVITY WHILE USING. IT WAS NOT TAMPERED WITH. TZ MEDICAL INC MODEL CLARUS 30.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5117741 ON 05/25/2023 TO UPDATE PROCODE TO DSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666650 HOLTER MONITOR DETECTOR AND ALARM, ARRHYTHMIA DSI TZ MEDICAL, INC. CLARUS 3
    666953 HOLTER MONITOR DETECTOR AND ALARM, ARRHYTHMIA DSI TZ MEDICAL, INC. CLARUS 3

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Other ATENOLOL, VYVANSE. MEDICAL HOLTER FOR 24 HOUR.