MAUDE Adverse Event Report: COMFORTABLE ELECTRIC CO., LTD. PURERELIEF XL EXTRAPLONG BACK & NECK HEATING PAD

Model Number	PEHPBACK-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	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rec-investigation-15 documented the investigation of this event.Manufacturer investigated the unit, which was returned by the customer.The unit was found to be functioning within specifications.No issues were found with the performance of the unit.Manufacturer reviewed production records and quality inspection records and no issues were identified with the production of the lot.Third party quality control inspection report for the lot was reviewed.No issues were identified with the qc inspection.Complaint analysis was conducted for pehpback-g as well as pehpback-sg and pehpback-cg which are similar models of different color.No burn complaints for pehpback-sg or pehpback-cg event rate analysis: (b)(4).No issues identified.Based upon the customer's pre-existing conditions of neck fusion surgery, under the influence of percocet during the event, congestive heart failure and diabetes, the most likely root cause of this event is the contributing factors of the customers impaired state not being able to feel the skin burning and poor circulation leading to insufficient healing and thus sepsis situation.There are clear warnings on the heating pad cord tag and the user manual stating: 3.This pad is not to be used by or on an incapacitated person, sleeping or unconscious person, or a person with poor blood circulation unless carefully attended.4.Do not use on areas of insensitive skin.5.Burns can occur regardless of setting, check skin under pad frequently.
Event or Problem Description
On (b)(6) 2024, the customer (complainant) emailed bdb stating that "she received 3rd degree burns on her back of her neck on (b)(6) 2024 and was hospitalized for being septic and is now in a wound clinic to get the burns healed." the customer provided photos.Photograph with blister is the day the burn occurred (b)(6) 2024.The second photo of the red area was taken (b)(6) 2024.On (b)(6) 2024 bdb customer service emailed customer with questions and on (b)(6) 2024 with further questions.The following is the detail from the customer answers to questions: the customer purchased the pehpback-g heating pad in 2023 and had used it two to three times per week.The customer had neck fusion surgery on (b)(6) 2023.On (b)(6) 2024 the customer came home from work and used the pad on level 3 for about 45 minutes.She felt warmth but did not feel any burning sensation when using the pad.The customer was taking medications from the surgery, percocet.She sat up, took the heating pad off and her husband noticed the burn and said her back had a blister on it and looked horrible.Customer went to her family doctor on (b)(6) 2024, he took pictures and gave her silverdine cream.She did that for several weeks.The blister crusted over with black.She has severe asthma and went septic on (b)(6) 2024.She was in the hospital from (b)(6) 2024.After hospital they sent her to a wound care center every other week, to debride and clean and cover with medicine and bandage.She changes the bandage every other day.Customer has asthma, high blood pressure, fibromyalgia, congestive heart failure, sinus problems, bladder problems and has had a gastric bypass.Customer sent photographs of her medical records, however, they are not readable.

• Brand Name: PURERELIEF XL EXTRAPLONG BACK & NECK HEATING PAD
• Common Device Name: HEATING PAD
• Manufacturer (Section D): COMFORTABLE ELECTRIC CO., LTD.; tonggu road 46, shizia village; dalang town; dongguan, guangdong province 51810 8; CH 518108
• Manufacturer (Section G): COMFORTABLE ELECTRIC CO., LTD.; tonggu road 46, shizia village; dalang town; dongguan, guangdong province 51810 8; CH 518108
• Manufacturer Contact: karen wiseman ; 2803 s. yale st; santa ana, CA 92704 ; 7146680300
• MDR Report Key: 19638918
• Report Number: 3011077581-2024-00010
• Device Sequence Number: 7399865
• Product Code: IRT
• UDI-Device Identifier: 00817387020732
• UDI-Public: (01)00817387020732(11)210813
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/28/2024

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: PEHPBACK-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 62 YR
• Patient Sex: Female