BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURETEMP

    MDR report key: 449854 · Received March 19, 2003

    Report

    Report Number
    1316463-2003-00002
    Event Type
    Other
    Date Received
    March 19, 2003
    Date of Event
    February 19, 2003
    Report Date
    March 19, 2003
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TOOK A RECTAL TEMPERATURE AND THE UNIT REGISTERED LOW BY ONE TO TWO DEGREES F AS COMPARED TO READINGS TAKEN FROM OTHER THERMOMETERS. THE PT ACTUALLY DID HAVE A HIGHER FEVER THAN WHAT WAS REGISTERED USING THIS UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURETEMP CLINICAL ELECTRONIC THERMOMETER FLL WELCH ALLYN, INC. 01679-002 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other