MAUDE Adverse Event Report: DONGGUAN HEAT APPLIANCE CO. PUREPURERELIEF 12X24 DELUXE HEATING PAD - GRAY

Model Number	PEHPVAL-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	08/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Received -investigation-7 ongoing.(b)(4) burn complaint rate (staying within 200 character limit).
Event or Problem Description
(b)(6) emailed bear down brands on 19-aug-2023 and stated that her partner had purchased the heating pad for her in may and she sustained second degree burns last week (assumed approximate date of incident as 10-aug-2023) by using it.She has sought medical attention for the burns.She wants to know our policy on defective products and what the compensation for this issue would be.On 24aug23 (b)(6) replied via email with answers to the following questions: the heat setting i had it on was low.She was in mexico when the burn occurred.She will send photographs.She wants to know if there is financial compensation for the expenses she incurred due to the burn.On 28/29-aug-2023 (b)(6) confirmed that the unit was purchased at target in hawaii.She confirmed the model number as pehpval-g.The customer's home address is (b)(6), the unit was purchased in hawaii and the incident occurred in mexico.

• Brand Name: PUREPURERELIEF 12X24 DELUXE HEATING PAD - 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: 19274849
• Report Number: 3011077581-2024-00005
• Device Sequence Number: 15365953
• Product Code: IRT
• UDI-Device Identifier: 00817387020596
• UDI-Public: (01)00817387020596(11)YYMMDD
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: PEHPVAL-G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2023
• 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