BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADT HEALTH WATCH BAND

    MDR report key: 12008129 · Received June 15, 2021

    Report

    Report Number
    MW5101917
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ADT LLC DBA ADT SECURITY SERVICES
    Product Code
    QDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED TO REPORT AN ADVERSE REACTION TO HER ADT HEALTH WATCH BAND. PATIENT STATED SHE WORE THE BAND FOR LESS THAN 5 DAYS AND WHEN SHE TOOK OFF THE BAND SHE NOTICED A RED RASH UNDER WHERE THE DEVICE WAS. PATIENT STATED THE RASH WAS AN ALLERGIC REACTION TO LATEX RUBBER AND HAD TAKEN OFF A COUPLE LAYERS OF SKIN AND SEEMED TO BE GETTING WORSE. PATIENT IS VERY CONCERNED AND WORRIED FOR OTHER PEOPLE WHO MIGHT HAVE AN EVEN WORSE REACTION TO LATEX RUBBER AND DO NOT KNOW THIS DEVICE CONTAINS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894066 ADT HEALTH WATCH BAND ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER QDA ADT LLC DBA ADT SECURITY SERVICES M31A MHSEV4

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR