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

Model Number	25607
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Other
Additional Manufacturer Narrative
Received letter in mail referencing mw5187934 submitted by (b)(6).
Event or Problem Description
Heating pad overheated causing burns/damage to property but patient was not harmed.

• Brand Name: HANDY SOLUTIONS NECK AND SHOULDER 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: 25381116
• Report Number: 1000065475-2026-00017
• Device Sequence Number: 9279596
• 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): 06/03/2026
• Report Date (Section F): 06/03/2026

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2026
• Device Age: 1 YR
• Date Report to Manufacturer: 06/03/2026
• 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: 58 YR
• Patient Sex: Female
• Date Report Sent to FDA: 06/03/2026