BEUDAMED
    FDA Adverse Event Other Summary report: N

    GERATHERM

    MDR report key: 275913 · Received May 1, 2000

    Report

    Report Number
    MW1018770
    Event Type
    Other
    Date Received
    May 1, 2000
    Date of Event
    April 28, 2000
    Report Date
    May 1, 2000
    Manufacturer
    RG ENTERPRISES, INC.
    Product Code
    FLK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THERMOMETER READING IS ALWAYS BETWEEN 0.5 AND 0.9 DEGREES F LESS THAN THE ACTUAL TEMPERATURE. DEVICE WAS BEING USED AS A BASAL THERMOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GERATHERM MERCURY FREE THERMOMETER FLK RG ENTERPRISES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other