GERMATHERM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-04 for GERMATHERM manufactured by R.g. Medical Diagnostics.

Event Text Entries

[32981575] Reporter states that, she placed a thermometer in her child's mouth and the tip broke inside his mouth. However, she was able to retrieve the broken piece by asking the child to spit it out. She is concerned with the material integrity of the product (thermometer).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5058368
MDR Report Key5274062
Date Received2015-12-04
Date of Report2015-12-04
Date of Event2015-11-29
Date Added to Maude2015-12-08
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGERMATHERM
Generic NameTHERMOMETER
Product CodeFLK
Date Received2015-12-04
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerR.G. MEDICAL DIAGNOSTICS


Patients

Patient NumberTreatmentOutcomeDate
10 2015-12-04

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