FDA.reportPublic FDA data

MAUDE MDR 9578262

MDR report key
9578262
Report number
1832415-2019-10995
Event key
0
Event type
3
Date received
2020-01-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL GREEN
Address
US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMOPHORETHERMOPHOREBATTLE CREEK EQUIPMENTIRT055R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-100

Event Narratives#

D

Patient 1

CUSTOMER STATED, "SHE SMELLED SMOKE AND FELT THE PAD WAS VERY HOT. SHE RELEASED THE LEVER AND THE PAD WAS STILL GETTING HOTTER. SHE SAW THE EMBERS UNDER THE COVER AND GRABBED THE PAD AND JUMPED UP THEN THE PAD BURST INTO FLAMES. SHE TOOK THE PAD OUT SIDE, THREW IT AND WENT AND GOT A BUCKET OF WATER AND DOUSED THE PAD, PUTTING THE FIRE OUT." CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS NOT RETURNED. LOT CODE INFORMATION WAS NOT PROVIDED. AN INVESTIGATION INTO SIMILAR FEEDBACKS FOR FIRE FOUND THAT THE PRIMARY CAUSE OF SIMILAR REPORTED ISSUES WERE CAUSED BY CUSTOMER MISUSING THE PRODUCT BY LAYING ON/ FOLDING THE PAD WHILE IN USE. IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS". THE INVESTIGATION IS INCONCLUSIVE WITHOUT THE RETURNED PRODUCT. FURTHER DETERMINATION INTO THE ROOT CAUSE OF THE ISSUE WILL BE CONDUCTED WHEN DEVICE OR ADDITIONAL INFORMATION IS OBTAINED.