*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-05 for * manufactured by Medline.

Event Text Entries

[21952411] Thermometer from care bag would not shake down. Pt did not have a thermometer at home.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number90292
MDR Report Key90292
Date Received1997-05-05
Date of Report1997-05-01
Date of Event1997-04-22
Date Facility Aware1997-04-22
Report Date1997-05-01
Date Added to Maude1997-05-14
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameORAL THERMOMETER
Product CodeFLK
Date Received1997-05-05
Model NumberNA
Catalog NumberNA
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeUNKNOWN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key89246
ManufacturerMEDLINE
Manufacturer Address* MUNDELEIN IL 60060 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-05-05

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