FDA Adverse Event
Malfunction
Summary report: N
CURAPLEX
MDR report key: 22589574
·
Received July 24, 2025
Report
- Report Number
- 3003674698-2025-01019
- Event Type
- Malfunction
- Date Received
- July 24, 2025
- Date of Event
- June 5, 2025
- Report Date
- July 24, 2025
- Manufacturer
- MEDSOURCE LABS LLC
- Product Code
- LNZ
- UDI-DI
- 00815277024358
- PMA / PMN Number
- K080339
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE BALLOON INFLATED, THEN DEFLATED AFTER APPROXIMATELY 2 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1457034 | CURAPLEX | CURAPLEX SELECT ENDOTRACHEAL TUBE WITH STYLETTE 8MM CUFFED | LNZ | MEDSOURCE LABS LLC | 2113-10280 | 1011834 | 00815277024358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |