FDA Adverse Event
Malfunction
Summary report: N
DISPOSABLE LARYNGOSCOPE BLADE
MDR report key: 293265
·
Received August 25, 2000
Report
- Report Number
- 1044265-2000-00038
- Event Type
- Malfunction
- Date Received
- August 25, 2000
- Date of Event
- July 28, 2000
- Report Date
- July 28, 2000
- Manufacturer
- SIMS PORTEX INC.
- Product Code
- EQN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE LARYNGOSCOPE BLADE WAS BEING UTILIZED FOR INTUBATION WHEN TWO PIECES OF THE PLASTIC FIBER-OPTIC LIGHT COLUMN ALLEGEDLY FELL INTO THE PT'S AIRWAY. THE PT WAS TURNED PRONE AND BOTH PIECES WERE RETRIEVED WITHOUT PT COMPROMISE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DISPOSABLE LARYNGOSCOPE BLADE | LARYNGOSCOPE BLADE | EQN | SIMS PORTEX INC. | NA | 9K0664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |