FDA.reportPublic FDA data

MAUDE MDR 1352219

MDR report key
1352219
Report number
1022819-2009-00089
Event key
0
Event type
3
Date received
2009-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MICHAEL TREAS
Address
4717 ADAMS RD. HIXSON TN 37343 US
Phone
423-423-4238
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1E-2CHATTANOOGA GROUPIRQ28022802N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-2701. O

Event Narratives#

D

Patient 1

THE PATIENT RECEIVED THREE BLISTERS ON THEIR HEEL DURING A HEAT THERAPY, USING MOIST HEAT PACS. THE PATIENT WAS TREATED WITH HEAT THERAPY FOR AN UNKNOWN INJURY. THE PATIENT COMPLETED THE TREATMENT WITH NO REPORTED DISCOMFORT. A WEEK LATER, THE PATIENT RETURNED FOR ADDITIONAL THERAPY AND THE CLINICIAN WAS INFORMED OF THE RESULTANT BLISTERS. THE ASSISTANT COULD NOT RECALL THE SIZE OF THE BLISTERS, TREATMENT DETAILS, DEVICE DETAILS, OR CONCLUSION OF THE INCIDENT. THE ASSISTANT COULD NOT CONFIRM THE MEDIA TEMPERATURE OF THE DEVICE, WHICH HEATED THE PACKS. THE ASSISTANT REQUESTED TRAINING ON THE DEVICE USAGE AND SUGGESTED THAT A THERMOMETER BE INCLUDED WITH THE DEVICE.

N

Patient 1

AWAITING RETURN OF THE DEVICE AND EVALUATION. THE EVALUATION RESULTS WILL BE REPORTED TO THE FDA - MDR.