BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL TEMPLE THERMOMETER

    MDR report key: 3870201 · Received June 6, 2014

    Report

    Report Number
    MW5036544
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BESTMED LLC
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PURCHASED THIS THERMOMETER COUPLE OF MONTHS BACK AND FOUND THIS REVIEW THAT REPORTS THE SAME PROBLEM ALMOST THREE YEARS LATER AND IT IS STILL FOR SALE AT (B)(4). IT READS 98.5 OR 96.7 WHEN I TRIED ON MYSELF. MY 2 YEAR OLD IS BURNING HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331477 DIGITAL TEMPLE THERMOMETER DIGITAL TEMPLE THERMOMETER FLL BESTMED LLC KD-2210

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR