GERATHERM MERCURY FREE FEVER THERMOMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-17 for GERATHERM MERCURY FREE FEVER THERMOMETER manufactured by Geratherm Medical Ag, Germany-exclusively For Rg Medical Diagnostics.

Event Text Entries

[15006064] The subject is a temperature thermometer that shows temperature in fahrenheit and celsius. Basic mathematical conversion establishes that 37 deg c equals 98. 6 deg f. I bought two thermometers from company, and yesterday discovered that the fahrenheit mark for 98. 6 is not across from the celsius mark for 37 deg. My wife reads in celsius and i read in fahrenheit, thus an argument ensues as to what was my real temperature. The fahrenheit reading showed 98. 6 -normal- but the celsius reading showed 37. 2 celsius -slight fever-. There is a fundamental error/flaw in the scale on the thermometer and it should be corrected. The product is manufactured by geratherm medical- exclusively for rg medical diagnostics. Since it appears that "fever" thermometers fall under fda regulation, i am requesting that the fda take steps to have this error/flaw corrected, flawed devices removed from shelves throughout the usa. Further, if the fda has the authority, require geratherm to replace by exchanging the flawed device with a corrected device, and to do so through all of its various distributors throughout the usa. The device, a "fever" thermometer has a flawed scale between celsius and fahrenheit. The scale shows 98. 6 f to equal 37. 2 c on the device, leaving the patient baffled as to which side of the scale is correct. The normal human temperature is 98. 6 f and 37c. Mathematically, 98. 6 f equals 37c. The device scale is incorrect. The device should be pulled from shelves throughout the usa, and people with defective devices should have them replaced by geratherm at no cost by an exchange at each and every geratherm distributor throughout the usa.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5010820
MDR Report Key1366570
Date Received2009-04-17
Date of Report2009-04-17
Date of Event2009-04-16
Date Added to Maude2009-04-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameGERATHERM MERCURY FREE FEVER THERMOMETER
Generic NameORAL FEVER THERMOMETER
Product CodeFQZ
Date Received2009-04-17
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerGERATHERM MEDICAL AG, GERMANY-EXCLUSIVELY FOR RG MEDICAL DIAGNOSTICS


Patients

Patient NumberTreatmentOutcomeDate
10 2009-04-17

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