FDA Adverse Event
Injury
Summary report: N
KOZEE
MDR report key: 21816686
·
Received April 10, 2025
Report
- Report Number
- 3010168054-2025-00002
- 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 KOZEE DEVICE CAUSED A BURN IN THE O.R. THE HEALTH PROFESSIONAL AT ST. JOSEPH'S -CANDLER (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 |
|---|---|---|---|---|---|---|---|
| 1664940 | KOZEE | KOZEE | DWJ | JIANGMEN DACHENG MEDICAL EQUIPMENT CO., LTD. | M21507 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |