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 Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Member called in (b)(6) 2026 and stated that on (b)(6) she tried to use product at night on her back and it caught fire on her mattress.

• 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 rd; jiangbei, ningbo zhejiang 31503 3; CH 315033
• MDR Report Key: 24667907
• Report Number: 1000065475-2026-00005
• Device Sequence Number: 9244103
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/23/2026
• Report Date (Section F): 03/23/2026

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: 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: 02/25/2026
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/25/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/23/2026