FDA Adverse Event
Injury
Summary report: N
KOZEE
MDR report key: 21816634
·
Received April 10, 2025
Report
- Report Number
- 3010168054-2025-00001
- Event Type
- Injury
- Date Received
- April 10, 2025
- Date of Event
- March 11, 2025
- Report Date
- April 10, 2025
- Manufacturer
- JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD.
- Product Code
- DWJ
- PMA / PMN Number
- K231596
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
GENTHERM MEDICAL, LLC., IS REPRESENTING THE MANUFACTURER AND IS SUBMITTING THIS REPORT ON THEIR BEHALF. COMPLAINT#: (B)(4) RECEIVED BY GENTHERM MEDICAL, LLC., ON MARCH 18, 2025.
Description of Event or Problem · 0
CUSTOMER REPORTED THE KOZEE DEVICE CAUSED A BURN IN THE OPERATOR ROOM. THE HEALTH PROFESSIONAL AT (B)(6) (USER FACILITY) TREATED THE PATIENT IN THE OPERATING ROOM ON (B)(6) 2025 USING THE KOZEE M21507 TEMPERATURE MANAGEMENT SYSTEM, AND THEN FOUND THE PATIENT HAD A SLIGHT REDDENING OF THE SKIN, BUT OTHERWISE THE PATIENT HAD NO OTHER ABNORMALITIES AND ALSO FELT NO DISCOMFORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470831 | KOZEE | KOZEE | DWJ | JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD. | M21507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |