MAUDE Adverse Event Report: CARDICARE DMI; HEATING PAD

Model Number	619-5133-1900
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074)
Date of Event	12/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported using heating pad on elbow and after 1 hour it caused a burn on bottom of elbow.
Additional Manufacturer Narrative
User was contacted twice requesting additional infomation.

• Brand Name: DMI
• Common Device Name: HEATING PAD
• Manufacturer (Section D): CARDICARE; 9 yan an road; wu shan town plaza, unit 7003; hangzhou, 31000 2; CH 310002
• MDR Report Key: 21240572
• Report Number: 1000143485-2025-25886
• Device Sequence Number: 14368577
• Product Code: IRT
• UDI-Device Identifier: 00041298051336
• UDI-Public: 00041298051336
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/27/2025
• Report Date (Section F): 01/27/2025

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
• Device Lot Number: 110191222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/27/2024
• Device Age: 2 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• 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 Age: 47 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Date Report Sent to FDA: 01/27/2025