THERMOMETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-15 for THERMOMETER manufactured by Ferno-washington, Inc..

Event Text Entries

[15674748] Customer claims thermometer is not registering correctly. No injuries incurred.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1523574-1998-00039
MDR Report Key173104
Report Source05
Date Received1998-06-15
Date of Report1998-05-15
Date Mfgr Received1998-05-15
Date Added to Maude1998-06-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTHERMOMETER
Generic NameTHERMOMETER
Product CodeFLK
Date Received1998-06-15
Model NumberNA
Catalog NumberNA
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key168314
ManufacturerFERNO-WASHINGTON, INC.
Manufacturer Address70 WEIL WAY WILMINGTON OH 45177 US


Patients

Patient NumberTreatmentOutcomeDate
10 1998-06-15

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