* 211869

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-19 for * 211869 manufactured by Florida Medical Industries, Inc. Tem-con Thermometer Div..

Event Text Entries

[18475464] Thermometer will not shake down.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1013032
MDR Report Key150262
Date Received1998-02-19
Date of Report1998-02-19
Date of Event1998-02-18
Date Added to Maude1998-02-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameDUAL THERMOMETER F & C GLASS WITH MERCURY
Product CodeFLK
Date Received1998-02-19
Model NumberNA
Catalog Number211869
Lot Number39B
ID NumberOUR STOCK #4284
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key146408
ManufacturerFLORIDA MEDICAL INDUSTRIES, INC. TEM-CON THERMOMETER DIV.
Manufacturer Address3131 US. HWY'S 27/441 N. FRUITLAND PARK FL 34731 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-02-19

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