BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW

    MDR report key: 8565790 · Received April 30, 2019

    Report

    Report Number
    MW5086283
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 23, 2019
    Report Date
    April 28, 2019
    Manufacturer
    ARC DEVICES USA, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL BATTERIES (BRAND IS (B)(6)) EXPLODED INSIDE OF THE THERMOMETER, CAUSING IT TO FLY APART WITH CONTENTS (LYE) ALL OVER THE INSIDE OF THE MEDICINE CABINET. ALL MEDICATIONS INSIDE WERE PENETRATED WITH THE SODIUM HYDROXIDE AND HYDROCHLORIC ACID AND HAD TO BE THROWN OUT. THIS IS A DANGER TO CHILDREN. I'VE SEEN MANY OTHER REPORTS ON (B)(6) CONSUMER COMMENTS. THIS COULD HAVE EXPLODED ON A CHILD'S NIGHTSTAND OR WHEN THEIR TEMPERATURE IS BEING TAKEN. THERMOMETER EXPLODED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356710 ARC DEVICES LTD INSTATEMP THERMOMETER OF TOMORROW THERMOMETER, ELECTRONIC, CLINICAL FLL ARC DEVICES USA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other