MAUDE Adverse Event Report: JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD. KOZEE

Model Number	M21507
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports a burn to the patient's skin.
Additional Manufacturer Narrative
Gentherm medical, llc., is representing the manufacturer and is submitting this report on their behalf.Complaint #(b)(4) received by gentherm medical, llc., on (b)(6) 2025.

• Brand Name: KOZEE
• Common Device Name: KOZEE
• Manufacturer (Section D): JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.; no. 8, jiaobei hengkeng south; jianghai district; jiangmen city, guangdong province 52904 0; CH 529040
• Manufacturer (Section G): JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.; no. 8 jiaobei hengkeng south; jianghai district; jiangmen city, guangdong province 52904 0; CH 529040
• Manufacturer Contact: touch zou ; no. 8, jiaobei hengkeng south; jianghai district; jiangmen city, guangdong province 52904-0 ; CH 529040
• MDR Report Key: 22059369
• Report Number: 3010168054-2025-00003
• Device Sequence Number: 7638897
• Product Code: DWJ
• UDI-Device Identifier: 06951013002649
• UDI-Public: 06951013002649
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K231596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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
• Device Model Number: M21507
• Device Catalogue Number: 507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown