BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER

    MDR report key: 19087530 · Received April 10, 2024

    Report

    Report Number
    MW5153710
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 9, 2024
    Manufacturer
    K-JUMP HEALTH CO., LTD.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OVER A PERIOD OF 2 MONTHS, BOUGHT 3 CVS HEALTH DIGITAL THERMOMETERS. PRODUCT: 5042842562, AND LOTS: 2307 AND 2306. THE THERMOMETERS GIVE READINGS THAT ARE 1-2 DEGREES LOWER THAN EXPECTED. WE CHECKED AGAINST OUR REGULAR THERMOMETERS AND HAD READINGS OF 98 DEGREES F AND HIGHER VS 97 DEGREES AND LOWER WITH THE CVS THERMOMETERS. DISTRIBUTED BY (B)(4) AND MANUFACTURED BY K-JUMP HEALTH CO, LTD IN CHINA. THESE THERMOMETERS ARE NOT PROPERLY CALIBRATED AND REPRESENT POOR QUALITY CONTROL. NO HARM TO US, BUT WE WERE PROVIDED 3 DIFFERENT THERMOMETERS AS PART OF OUR (B)(6) PROGRAM. EACH TIME WE COMPLAINED THEY JUST GAVE ANOTHER INACCURATE THERMOMETER. REFERENCE REPORTS: MW5153708, MW5153709.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808660 CVS HEALTH FLEXIBLE TIP DIGITAL THERMOMETER THERMOMETER, ELECTRONIC, CLINICAL FLL K-JUMP HEALTH CO., LTD. 42562 2306

    Patients

    Seq Age Sex Outcome Treatment
    1 Male