FDA.reportPublic FDA data

MAUDE MDR 9890297

MDR report key
9890297
Report number
1314800-2020-00016
Event key
0
Event type
3
Date received
2020-03-27
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
SONJA WILKINSON
Address
400 DONALD LYNCH BOULEVARD SUITE 300 MARLBOROUGH, MA US
Phone
490-490-4907
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SOFTHEATELECTRIC HEATING PADKAZ USA, INC., A HELEN OF TROY COMPANYIRTHP75006914SMTY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2701. O; 2. R

Event Narratives#

D

Patient 1

A CONSUMER STATED THAT SHE HAD ALLEGEDLY RECEIVED BURNS ON HER BUTTOCKS WHILE USING A HEATING PAD APPROXIMATELY 3 MONTHS AGO, AND MEDICAL ATTENTION WAS SOUGHT ABOUT A MONTH AFTER THE INCIDENT OCCURRED. SHE STATED THAT SHE RECEIVED A THIRD DEGREE BURN, AND THAT FOLLOW-UP CARE WILL BE NEEDED. THE CONSUMER STATED THAT SHE WAS LAYING ON TOP OF THE HEATING PAD AT THE TIME THAT THE INJURY OCCURRED. THE INSTRUCTIONS FOR PROPER USE CLEARLY STATE "DANGER: IF USED IMPROPERLY, THIS PRODUCT CAN CAUSE SEVERE BURNS TO SKIN, AND DAMAGE TO PROPERTY.", "DO NOT USE WHILE SLEEPING.", AND "THIS HEATING PAD IS INTENDED FOR USE ON TOP OF YOUR BODY. DO NOT SIT OR LIE ON TOP OF THE HEATING PAD. NEVER PLACE PAD BETWEEN YOURSELF AND CHAIR, SOFA, BED OR PILLOW."