M-2 2402-2403-2404 2402-2404

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-03 for M-2 2402-2403-2404 2402-2404 manufactured by Chattanooga Group, Inc..

Event Text Entries

[20922537] Broken thermostat in hydrocollator unit causing temperature to rise above the recommended operating range resulting in first degree burns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number617984
MDR Report Key617984
Date Received2005-06-03
Date of Report2005-06-03
Date of Event2005-05-05
Report Date2005-06-03
Date Reported to FDA2005-06-03
Date Added to Maude2005-06-30
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameM-2
Generic NameHYDROCOLLATOR
Product CodeIRQ
Date Received2005-06-03
Model Number2402-2403-2404
Catalog Number2402-2404
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age2 YR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key607670
ManufacturerCHATTANOOGA GROUP, INC.
Manufacturer Address4717 ADAMS ROAD HIXSON TN 37343 US


Patients

Patient NumberTreatmentOutcomeDate
10 2005-06-03

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