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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; ELECTRIC HEATING PAD
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KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; ELECTRIC HEATING PAD Back to Search Results
Model Number HP750
Device Problem Use of Device Problem (1670)
Patient Problem Partial thickness (Second Degree) Burn (2694)
Event Date 11/21/2019
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 second degree burns on her pelvis while using a heating pad, and medical attention was sought for her injuries.She stated that she thinks her wound may be infected, and will likely be seeking additional medical attention.The consumer stated that she primarily used the heating pad while laying down with the heating pad on top of her body, but sometimes she lays on her side with the pad underneath her.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." 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 second degree burns on her pelvis while using a heating pad, and medical attention was sought for her injuries.She stated that she thinks her wound may be infected, and will likely be seeking additional medical attention.The consumer stated that she primarily used the heating pad while laying down with the heating pad on top of her body, but sometimes she lays on her side with the pad underneath her.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.".
 
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Brand Name
SOFTHEAT
Type of Device
ELECTRIC HEATING PAD
Manufacturer (Section D)
KAZ USA, INC., A HELEN OF TROY COMPANY
marlborough MA 01752
MDR Report Key9504142
MDR Text Key182229714
Report Number1314800-2019-00052
Device Sequence Number1
Product Code IRT
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 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberHP750
Device Lot Number15312SMT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Date Manufacturer Received12/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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