MAUDE Adverse Event Report: NINGBO UNICO PRODUCTS CO., LTD HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD WRAP; PAD, HEATING, POWERED

Model Number	25607
Medical Device Problem Codes	Fire (1245); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/11/2026
Type of Reportable Event	Other
Additional Manufacturer Narrative
Importer submission for report received from fda.Report forwarded to manufacturer on 04/08/2026.Mw5186416.
Event or Problem Description
Patient used neck and back heating pad from navajo manufacturing company inc.Product was item #448 from (b)(6) otc catalog heating pad wrap for shoulder and neck.Patient fell asleep on it and woke up to the smell of fire.Patient's pillow had a hole burned into it and patient had a burn on her neck that blistered.Patient stopped use immediately.

• Brand Name: HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD WRAP
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): NINGBO UNICO PRODUCTS CO., LTD; floor.3th, building 5, no.5; hongda rd; jiangbei, ningbo zhejiang 31503 3; CH 315033
• MDR Report Key: 24819529
• Report Number: 1000065475-2026-00010
• Device Sequence Number: 20336385
• Product Code: IRT
• UDI-Device Identifier: 00024291256076
• UDI-Public: 00024291256076
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026
• Report Date (Section F): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 25607
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2026
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 04/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: Black Or African American
• Date Report Sent to FDA: 04/08/2026