MAUDE Adverse Event Report: DONGGUAN HEAT APPLIANCE CO. PURERELIEF XXL ULTRA-WIDE MICROPLUSH HEATING PAD

Model Number	PEHPWD2-G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) called bear down brands on (b)(6) 2023 to report that her heating pad, pehpwide had burned her.Customer stated she had a third degree burn and had gone to the hospital for medical care.Customer did not state the actual date of the hospital visit.The unit had been used previously and she could not remember what level it was set on but probably 3.She usually uses the pad one hour per session.Bear down brands called customer for further follow up on (b)(6) 2024.Customer stated that she experienced a burn on their left side upper thigh.She fell asleep not knowing she had laid on the remote and the heating pad must have turned on accidently.On (b)(6) customer replied to voice message left by bear down brands.Customer stated that they had been to the doctor three times.(b)(6) 2024 bear down called customer again and received the following answers: customer changed the model number of the product for this incident to pehpwd2-g she was wearing pants, she does not recall how long exactly the unit was in use, she fell asleep she had used the pad for over 4 monts her burn has been been classified as second to third degree and she has a follow up appointment on (b)(6) 2024.Customer provided photos of burn.
Additional Manufacturer Narrative
Rec-investigation-8 ongoing.0.004% adverse event rate no other burn complaints reported(staying within 200 characters).

• Brand Name: PURERELIEF XXL ULTRA-WIDE MICROPLUSH HEATING PAD
• Common Device Name: HEATING PAD
• Manufacturer (Section D): DONGGUAN HEAT APPLIANCE CO.; room 801, building 4 no.9,; jins hagang 1st road, dalang t; dongguan city, guangdong province ; CH
• Manufacturer (Section G): DONGGUAN HEAT APPLIANCE CO., LTD; room 801, building 4 no.9; jins hagang 1st road, dalang t; dongguan city, guangdong province ; CH
• Manufacturer Contact: karen wiseman ; 2803 s. yale st; santa ana, CA 92704 ; 7146680300
• MDR Report Key: 19274616
• Report Number: 3011077581-2024-00003
• Device Sequence Number: 18057310
• Product Code: IRT
• UDI-Device Identifier: 00817387025010
• UDI-Public: (01)00817387025010(11)YYMMDD
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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: PEHPWD2-G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown