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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Other
Additional Manufacturer Narrative
Received mw5186233 via email.
Event or Problem Description
Patient called to report receiving letter advising of overheating issue with heating pad (otc # 448) purchased from (b)(6) pharmacy otc department.Patient states she used the heating pad a few times since (b)(6) 2025.Patient states she lives in (b)(6) therefore does not need to use heating pad much due to (b)(6) warm temperatures.Patient states she noticed burn marks on mattress 3 to 4 weeks ago.Patient states she did not report it because she thought it was a "fluke." patient states she decided to report incident, after receiving letter notifying her of an overheating defect of the pad explained in the letter from (b)(6).Patient requesting replacement of her mattress.Patient did not suffer any permanent bodily injury.Patient states she still has the mattress and heating pad.

• 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: 24990567
• Report Number: 1000065475-2026-00014
• Device Sequence Number: 21343007
• Product Code: IRT
• UDI-Device Identifier: 00024291256076
• UDI-Public: 00024291256076
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 04/24/2026
• Report Date (Section F): 04/24/2026

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: 04/24/2026
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Race: Black Or African American
• Date Report Sent to FDA: 04/24/2026