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

Model Number	25607
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Other
Additional Manufacturer Narrative
In reference to mw5188259 received via email from fda.
Event or Problem Description
Patient does not recall exact date but reports taking this heating pad out of the box around when it was delivered to her on (b)(6) 2025, plugging it into an electrical outlet and leaving it on her bed.She left the room and upon returning to the room she noticed that it was smoking and her it had burned a hole in her bedsheet.She then discarded of the heating pad and did not report any injuries.

• Brand Name: HANDY SOLUTIONS NECK AND SHOULDERS HEATING PAD
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): NINGBO UNICO PRODUCTS CO., LTD; floor.3th, building 5; no. 5 hongda road, jiangbei; ningbo, zhejiang 31503 3; CH 315033
• MDR Report Key: 25381180
• Report Number: 1000065475-2026-00016
• Device Sequence Number: 10556516
• Product Code: IRT
• UDI-Device Identifier: 00024291256076
• UDI-Public: 00024291256076
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/29/2026
• Report Date (Section F): 05/29/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/29/2026
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 05/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• 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
• Date Report Sent to FDA: 05/29/2026