MAUDE Adverse Event Report: DONGGUAN HEAT APPLIANCE CO. PURERELIEFXL KING SIZE HEATING PAD CHARCOAL GRAY

Model Number	PEHPAD24-G
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rec-investigation-9 ongoing.Customer descriptions are not verifiable, no photos etc.Complaint analysis: 1 total burn complaint with medical attention sought (this one), zero fire complaints 01jan2023-22mar24, (b)(4) adverse event rate one other burn complaints reported for total burn complaint rate of (b)(4).
Event or Problem Description
(b)(6) called bear down brands on 08:15 am on (b)(6) 2023 to report that the previous day, (b)(6) 2023 the heating pad caught on fire, the cord melted and caught on fire and that all the pad burned and only the very tiip of it is left.She was burned on the back.She stated that she went to the emergency room for treatment.(it is implied but not stated that she went to the er on (b)(6) 2023) it was being used in her living room and had been on for about 2 hours.She uses the unit every day.Bear down requested photographs of her burn but (b)(6) refused saying it was a hippa violation for us to request the photos.She did not provide specifics on the type or exent of the burn.Bear down requested the pad returned or photos of the pad and anna said that there was nothing left of the pad, she could not provide nor could she provide photos.She did not state that there was any property damage.The unit was purchased on amazon on (b)(6) 2022.

• Brand Name: PURERELIEFXL KING SIZE HEATING PAD CHARCOAL GRAY
• 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: 19274595
• Report Number: 3011077581-2024-00004
• Device Sequence Number: 15368448
• Product Code: IRT
• UDI-Device Identifier: 00853975005644
• UDI-Public: (01)00853975005644(11)YYMMDD
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: PEHPAD24-G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• 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