FDA.reportPublic FDA data

MAUDE MDR 9569295

MDR report key
9569295
Report number
3010805625-2020-00001
Event key
0
Event type
3
Date of event
2019-12-14
Date received
2020-01-09
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 MILES
Address
303 NELSON AVE. NEOSHO MO 64850 US
Phone
417-417-4174
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SUNBEAMHEATING PADSUNBEAM PRODUCTS, INC.IRT720-905Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-0901. O

Event Narratives#

N

Patient 1

CONSUMER ADMITS TO LAYING ON THE HEATING PAD WHICH IS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THERE IS AN INSTRUCTION THAT STATES, "DO NOT SIT ON, AGAINST, OR CRUSH PAD-AVOID SHARP FOLDS. PLACE PAD ON TOP OF AND NOT UNDER THE PART OF BODY NEEDING HEAT" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. THERE IS AN INSTRUCTION THAT STATES, "DO NOT PLACE ANYTHING OVER THE HEATING PAD WHILE IN USE OR PLUGGED IN, SUCH AS A TOWEL, BLANKET, CLOTHING, OR ANY OTHER INSULATING MATERIAL, AND NEVER ALLOW HEATING PAD TO WRAP AROUND ITSELF" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. 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'S DAUGHTER ALLEGES HER MOTHER HAD LEANED AGAINST THE HEATING PAD WHILE IN HER RECLINER WATCHING TELEVISION AND RECEIVED A BURN ON HER RIGHT HIP NEAR HER BUTTOCK. THERE WAS NOT A REPORT OF PROPERTY DAMAGE WITH THIS INCIDENT.