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	Full thickness (Third Degree) Burn (2696)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024 (b)(6) emailed bear down brands to report: i am reaching out because i suffered third degree burns from a heating pad i recently purchased from (b)(6) on (b)(6) 2024 bear down brands received the following requested details regarding the incident: incident occured on 15jan24, product was on level 5 and used for 20 minutes.(b)(6) required a visit to urgent care on (b)(6) 2024 where they sent off a burn/wound culture and i required two antibiotics and spent several hundred dollars on wound dressings.They informed me it was a third degree burn.(b)(6) provided photographs of burn.Photographs of the burn provided.Medical records have not been provided to date.She was using the pad on her back for aches with no specific preexisting condition.
Additional Manufacturer Narrative
Rec-investigation-8 ongoing.(b)(4) % 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: 19275330
• Report Number: 3011077581-2024-00002
• Device Sequence Number: 20745485
• Product Code: IRT
• UDI-Device Identifier: 00817387025010
• UDI-Public: (01)00817387025010(11)230526
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: 02/06/2024
• Initial Report FDA Received Date: 05/09/2024
• 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 Age: 34 YR
• Patient Sex: Unknown