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

Model Number	25607 V1
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called to report receiving letter advising of overheating issue with heating pad (otc#448) purchased from pharmacy otc department.Patient states she used the heating pad a few times since 2025.Patient states she lives in, therefore does not need to use heating pad much due to 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.Patient requesting replacement of her mattress.Patient did not suffer any permanent bodily injury.Patient states she still has the mattress and heating pad.
Additional Manufacturer Narrative
The manufacturer received a report stating that the heating pad overheated, along with photos of the incident.The device was not returned for evaluation.The product label warned against use on soft surface and can't be covered during use, yet these actions were observed in the incident photos.Third-party testing confirmed the product does not overheat under correct use (see test report: zx260209-c060401) and no defects identified.

• Brand Name: HANDY SOLUTIONS
• Common Device Name: PAD, HEATING, POWERED
• Manufacturer (Section D): NINGBO UNICO PRODUCTS CO., LTD ; no. 5 hongda rd, jiangbei, ; ningbo,zhejiang china; ningbo, zhejiang 31500 0; CH 315000
• Manufacturer (Section G): NINGBO UNICO PRODUCTS CO., LTD ; no. 5 hongda rd, jiangbei, ; ningbo,china; ningbo, zhejiang 31500 0; CH 315000
• Manufacturer Contact: alice fei ; no. 5 hongda rd, jiangbei, ningbo,zhejiang china. ; ningbo, zhejiang 31500-0 ; CH 315000
• MDR Report Key: 25250529
• Report Number: 3030539818-2026-00012
• Device Sequence Number: 10534505
• Product Code: IRT
• UDI-Device Identifier: 00024291256076
• UDI-Public: 024291256076
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

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 V1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native