BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUTEMP PLUS

    MDR report key: 232097 · Received July 15, 1999

    Report

    Report Number
    MW1016743
    Event Type
    Malfunction
    Date Received
    July 15, 1999
    Date of Event
    June 20, 1999
    Manufacturer
    KEWTEC MEDICAL, INC.
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    TEMPERATURE PROBE DRIED OUT AND WAS NOT STICKING TO INFANT. TEMP AXILLARY 100.9. MOISTENED AND REAPPLIED. ONE HR LATER TEMP - 99.8 AXILLARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUTEMP PLUS HYDROGEL SKIN PROBE FMT KEWTEC MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY