FDA.reportPublic FDA data

MAUDE MDR 9781358

MDR report key
9781358
Report number
3007790958-2020-00019
Event key
0
Event type
3
Date of event
2020-02-11
Date received
2020-03-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MICHAEL MILES
Address
303 NELSON AVE. NEOSHO, MO US
Phone
455-455-4557
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUNBEAMHEATING PADSUNBEAM PRODUCTS, INC.IRT731-500N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0301. O

Event Narratives#

N

Patient 1

CONSUMER ADMITS TO SLEEPING WHILE USING THE HEATING PAD WHICH IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION.

D

Patient 1

CONSUMER ALLEGES FALLING ASLEEP WHILE USING THE HEATING PAD AND AWOKE TO A BURN ON HER LEFT ARM. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.