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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; HEATING PAD
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KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; HEATING PAD Back to Search Results
Model Number HP750
Device Problem Use of Device Problem (1670)
Patient Problem Full thickness (Third Degree) Burn (2696)
Event Date 05/28/2020
Event Type  Injury  
Manufacturer Narrative
Kaz usa, inc.Has requested that the product be returned to our company for testing, but it has not yet been received.
 
Event Description
A consumer stated that she had allegedly received third degree burns on her right hip while using a heating pad, and medical attention was sought for her injuries.The consumer stated that this incident occurred while she was sleeping with the heating pad, and she believes that the automatic shut-off malfunctioned.The instructions for proper use clearly state "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." kaz usa, inc.Has requested that the product be returned to our company for testing.
 
Event Description
A consumer stated that she had allegedly received third degree burns on her right hip while using a heating pad, and medical attention was sought for her injuries.The consumer stated that this incident occurred while she was sleeping with the heating pad, and she believes that the automatic shut-off malfunctioned.The instructions for proper use clearly state "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.".
 
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Brand Name
SOFTHEAT
Type of Device
HEATING PAD
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key10380248
MDR Text Key202060207
Report Number1314800-2020-00032
Device Sequence Number1
Product Code IRT
UDI-Device Identifier00328785000153
UDI-Public00328785000153
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberHP750
Device Catalogue NumberHP750V1
Device Lot Number01915SMT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2020
Date Manufacturer Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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