MAUDE Adverse Event Report: DONGGUAN HEAT APPLIANCE CO. PURERELIEF 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	Full thickness (Third Degree) Burn (2696)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Bear down brands received call from customer ((b)(6)) on (b)(6) 2024 reporting complaint.Heating pad brand new bought in february.Her son received third degree burns and now must have skin graft surgery.Product is pehpval-g.Purchased at target.Description on what occured: burn on his back, he had his shirt on, it was on for fifteen minutes and then turned off.He has a third degree burn.Event happened on (b)(6) 2024.S first time the son used it.Sent a picture to doctor after event (date of call to doctor not clear) and they went to urgent care.Son was taken to urgent care on (b)(6) 2024.(b)(6).Diagnosis was 1.Burn of uspecified body region, unspecified degree).Patient was given silver sulfadiazine 1% cream to apply topically to affected area daily and sent home with burn instructions to care for a third degree burn.Customer stated during the (b)(6) 2024 call to bdb that the cream was not sufficient to heal the burn.Customer provided document from unknown fnp (b)(6).(b)(6) unknown date, which shows that customer's son had an appointment with dr.(b)(6) on thursday (b)(6) 2024.Bear down brands did not receive medical report of (b)(6) 2024 visit with dr.(b)(6).Bear down brands received customers phone compliant on 07mar2024 after doctor visit and customer then stated physician recommended skin graft surgery.Skin graft surgery was scheduled for and completed on (b)(6) 2024 ((b)(6)).Bear down brands follow up with customer on 05apr2024 customer stated her son is doing alright and was able to shower.
Additional Manufacturer Narrative
Rec-investigation-7 ongoing.(b)(4).

• Brand Name: PURERELIEF 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: 19275221
• Report Number: 3011077581-2024-00001
• Device Sequence Number: 15037514
• Product Code: IRT
• UDI-Device Identifier: 00817387020596
• UDI-Public: (01)00817387020596(11)231023
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/05/2024

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: 03/07/2024
• 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: 14 YR
• Patient Sex: Male