MAUDE Adverse Event Report: CARDICARE DMI; HEATING PAD

Model Number	619-5133-1900
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Fluid Discharge (2686); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Request for unit to be returned.Device was not available for inspection at this time.Unit is over 5 years old and contains instructions not to use while sleeping.
Event or Problem Description
Due to joint paint, patient went to bed with heating pad on ankle and work up 4 hours later to pain.The next day patient had severe leg pain and the skin was peeling/blistering.Patient went to doctor and was told patient had 2nd degree burn.

• 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: 20471378
• Report Number: 1000143485-2024-25105
• Device Sequence Number: 7236321
• Product Code: IRT
• UDI-Device Identifier: 00041298051336
• UDI-Public: 00041298051336
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/17/2024
• Report Date (Section F): 10/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 619-5133-1900
• Device Lot Number: 90240719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/25/2024
• Device Age: 5 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2024
• 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: 34 YR
• Patient Sex: Female
• Patient Race: Black Or African American
• Date Report Sent to FDA: 10/17/2024