FDA.reportPublic FDA data

MAUDE MDR 7832345

MDR report key
7832345
Report number
MW5079497
Event key
0
Event type
3
Date of event
2018-08-14
Date received
2018-08-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMACAREPACK, HOT OR COLD REUSABLEPFIZER INC.IMEI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2901. O

Event Narratives#

D

Patient 1

AFTER PLACING THERMACARE WRAP ON THE JOINT AFTER PEELING OFF THE ADHESIVE BACKING PER THE INSTRUCTIONS. IT NEVER WARNED UP AT ALL. THE PRODUCT COMPLETELY MALFUNCTIONED AND DID NOT MEET ITS INTENDED USE. CLOSE TO TWO HOURS LATER, THERE WAS ABSOLUTELY NO INCREASE IN TEMPERATURE YET LABELING CLAIMS IT WORKS FOR UP TO 8 HOURS.