MAUDE Adverse Event Report: SHIJIAZHUANG WANGFENG TECHNOLOGY DMI - XL ELECTRIC HEATING PAD

Model Number	619-5133-1900
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Burn(s) (1757); Electric Shock (2554)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Distributor reported event.Distributor contacted for additional user and/or device information, none has been received.
Event or Problem Description
Item shocked user and burn mark appeared.

• Brand Name: DMI - XL ELECTRIC HEATING PAD
• Common Device Name: XL ELECTRIC HEATING PAD
• Manufacturer (Section D): SHIJIAZHUANG WANGFENG TECHNOLOGY; no.6 xingye street; xinle economic development zon; xinle, hebei 05070 0; CH 050700
• MDR Report Key: 23991465
• Report Number: 1000143485-2025-28162
• Device Sequence Number: 10522722
• Product Code: IRT
• UDI-Device Identifier: 00041298051336
• UDI-Public: 041298051336
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/07/2026
• Report Date (Section F): 01/07/2026

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: 619-5133-1900
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/11/2025
• Device Age: 2 MO
• Event Location: Home
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/07/2026