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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060); Unspecified Tissue Injury (4559)
Type of Reportable Event	Other
Additional Manufacturer Narrative
Received mw5187281 via email.
Event or Problem Description
Burn areas around right-side shoulder and neck.Also, right leg where prior surgery area where pins are due to coldness; skin water, open wound and then became a scar: pillow using burn mark and also the pad itself burned; still have it.Last used between 6 weeks -2 months ago.

• 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: 25249709
• Report Number: 1000065475-2026-00015
• Device Sequence Number: 9489874
• 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): 05/21/2026
• Report Date (Section F): 05/21/2026

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: 05/15/2026
• Event Location: Home
• Date Report to Manufacturer: 05/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2026
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 05/21/2026