BEUDAMED
    FDA Adverse Event Summary report: N

    TEMPA DOT SINGLE USE CLINICAL THERMOMETER

    MDR report key: 78685 · Received March 26, 1997

    Report

    Report Number
    MW1011039
    Date Received
    March 26, 1997
    Manufacturer
    3M HEALTHCARE
    Product Code
    FQZ
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DONOR COMPLAINS OF BAD TASTE WITH USE. THERMOMETERS SHOWED BLUE SMEARED DOT GRID WHEN REMOVED. IT APPEARS THAT PLASTIC LAMINATE IS LEAKING. CO TO INVESTIGATE IF OTHER COMPLAINTS RECEIVED ON THIS LOT OR INVESTIGATE POSSIBLE MISHANDLING IN SHIPPING OR STORAGE. TWO INCIDENTS REPORTED. USER FACILITY IS UNSURE OF UNREPORTED INCIDENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPA DOT SINGLE USE CLINICAL THERMOMETER SINGLE USE CLINICAL THERMOMETER FQZ 3M HEALTHCARE NA 3F476E

    Patients

    Seq Age Sex Outcome Treatment
    1 *