FDA Adverse Event
Malfunction
Summary report: N
CURAPLEX
MDR report key: 22542548
·
Received July 18, 2025
Report
- Report Number
- 3003674698-2025-00948
- Event Type
- Malfunction
- Date Received
- July 18, 2025
- Date of Event
- April 23, 2025
- Report Date
- July 18, 2025
- Manufacturer
- MEDSOURCE LABS LLC.
- Product Code
- LNZ
- UDI-DI
- 00815277024303
- PMA / PMN Number
- K080339
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE CUFF ON AN ET TUBE WAS OBSERVED TO BE DEFLATED AFTER INTUBATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405710 | CURAPLEX | CURAPLEX SELECT ENDOTRACHEAL TUBE WITH STYLETTE 7MM | LNZ | MEDSOURCE LABS LLC. | 2113-10270 | 1011220 | 00815277024303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |