FDA.reportPublic FDA data

MAUDE MDR 9673696

MDR report key
9673696
Report number
1832415-2020-11042
Event key
0
Event type
3
Date received
2020-02-05
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 EQUIPMENTIRT15500155016195Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-050

Event Narratives#

D

Patient 1

CUSTOMER STATED, "SMELLED AN ELECTRICAL BURNING ODOR. SHE LOOKED DOWN AND SAW A SPARK COME FROM THE CORD. SHE PUTS THE PAD ON THE WEDGE AND LAYS BACK ON IT. SOMETIMES SHE LAYS FLAT ON THE FLOOR ON THE PAD. SOMETIMES SHE WRAPS THE PAD AROUND HER LOWER LEG" CUSTOMER DID NOT CLAIM INJURY. PRODUCT WAS RETURNED. THE INVESTIGATOR OBSERVED A BURN MARK ON THE CORD AT THE BUTTERFLY. THE INVESTIGATOR DETERMINED THE BURN WAS CAUSED BY THE INSULATION OF THE WIRES BEING WORE DOWN, DUE TO EXCESSIVE FLEXING OF THE CORD. THE INVESTIGATOR OBSERVED EVIDENCE TO CORROBORATE THE USERS STATEMENT OF MISUSE OF LAYING ON AND WRAPPING THE PAD WHILE IN USE. THE IFU STATES, NEVER WRAP, HOLD, OR LOOP THE CORD IN ANY POSITION WHICH SHARPLY BENDS IT. IFU STATES, "DO NOT SIT ON, LIE ON, OR CRUSH PAD. AVOID SHARP FOLDS".