BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN THERMOSCAN INSTANT THERMOMETER, HM-2

    MDR report key: 175510 · Received July 2, 1998

    Report

    Report Number
    2084209-1998-00008
    Event Type
    Other
    Date Received
    July 2, 1998
    Date of Event
    May 20, 1998
    Report Date
    June 8, 1998
    Manufacturer
    BRAUN THERMOSCAN, INC.
    Product Code
    FLL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RETURNED HER THERMOMETER WITH NOTE TO BRAUN THERMOSCAN. FROM THIS NOTE, AND SUBSEQUENT CONVERSATION, FOLLOWING WAS LEARNED: CUSTOMER USED EAR THERMOMETER TO MONITOR HER DAUGHTER'S TEMPERATURE ON 5/18/1998 AND 5/19/1998. SOURCE SUSPECTED HER CHILD HAD FEVER BECAUSE CHILD FELT "REALLY HOT," WHICH SOURCE ATTRIBUTED TO CHILD'S TEETHING. IN NOTE, CUSTOMER REPORTED READINGS BETWEEN 98.6-99.2F, YET IN SUBSEQUENT CONVERSATION, CUSTOMER RECALLED THAT HIGHEST READING OBTAINED WAS 99.9F. ALL READINGS WERE TAKEN IN CHILE/ADULT MODE, WHICH IS INCORRECT FOR CHILD THIS AGE. UNIT WAS NOT USED ON 5/20/1998, DAY SEIZURE OCCURRED. THAT DAY, CHILD WAS AT HER AUNT'S HOUSE. AROUND 2:00 PM, WHEN CHILD WAS WATCHING TV, AUNT SAW HER SLOUCH OVER AND CONVULSING. INITIALLY, AUNT THOUGHT CHILD WAS CHOKING. POLICE CAME TO HOUSE, AND CHILD WAS TAKEN TO EMERGENCY ROOM. RECTAL READING OF 104.5 F WAS OBTAINED, AN INTRAVENOUS ADMINISTERED, BLOOD DRAWN, AND X-RAYS TAKEN. DR PRESCRIBED ANTIBIOTICS AND BELIEVED CHILD HAD EAR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN THERMOSCAN INSTANT THERMOMETER, HM-2 CLINICAL ELECTRONIC THERMOMETER FLL BRAUN THERMOSCAN, INC. HM-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Other