MAUDE Adverse Event Report: KAZ USA, INC., A HELEN OF TROY COMPANY SOFTHEAT; HEATING PAD

Model Number	HP215
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A consumer stated that her husband had allegedly received 2nd degree burns on his back while using a heating pad, and medical attention was sought for his injury.The consumer stated that he was using the heating pad in bed 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" 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 or Problem Description
A consumer stated that her husband had allegedly received 2nd degree burns on his back while using a heating pad, and medical attention was sought for his injury.The consumer stated that he was using the heating pad in bed 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" 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.".

• Brand Name: SOFTHEAT
• Common Device Name: HEATING PAD
• Manufacturer (Section D): KAZ USA, INC., A HELEN OF TROY COMPANY; marlborough MA 01752
• MDR Report Key: 10137596
• Report Number: 1314800-2020-00028
• Device Sequence Number: 19393448
• Product Code: IRT
• UDI-Device Identifier: 00328785000047
• UDI-Public: 00328785000047
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: HP215
• Device Lot Number: 26709ART
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 38 YR