BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPLE THERMOMETER DDT

    MDR report key: 6689057 · Received July 3, 2017

    Report

    Report Number
    MW5070810
    Event Type
    Malfunction
    Date Received
    July 3, 2017
    Report Date
    July 3, 2017
    Manufacturer
    BESTMED LLC, K-JUMP HEALTH CO.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING REPEATED ASSESSMENTS, THE THERMOMETER REGISTERED INACCURATE TEMP READINGS. THE PTS TEMPS WERE TAKEN AXILLARY UNTIL THE NEW THERMOMETER WAS PURCHASED. DTT TEMPLE THERMOMETER USED PER SHIFT EVERY 4 HOURS. DATES OF USE: (B)(6) 2015 - (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: CONGENITAL MYOPATHY. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464256 TEMPLE THERMOMETER DDT TEMPLE THERMOMETER FLL BESTMED LLC, K-JUMP HEALTH CO. KD-2201 KD-2201

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR