MAUDE Adverse Event Report: SHIJIAZHUANG WANGFENG TECHNOLOGY DMI; HEATING PAD

Model Number	619-5133-1900
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Unit was hot and did not shut off correctly causing a burn.
Additional Manufacturer Narrative
User has been contacted three times requesting additional information.

• Brand Name: DMI
• Common Device Name: 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: 22569960
• Report Number: 1000143485-2025-27238
• Device Sequence Number: 9348243
• Product Code: IRT
• UDI-Device Identifier: 00041298051336
• UDI-Public: 041298051336
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2025
• Report Date (Section F): 07/22/2025

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: 06/26/2025
• Event Location: Home
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2025
• 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: Male
• Date Report Sent to FDA: 07/22/2025