FDA Adverse Event
Malfunction
Summary report: N
9681900-1997-00035
MDR report key: 121220
·
Received September 17, 1997
Report
- Report Number
- 9681900-1997-00035
- Event Type
- Malfunction
- Date Received
- September 17, 1997
- Product Code
- CAE
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
A F/U CALL TO THE CRNA REVEALED: 1) THE SMALL HOLE INITIALLY REPORTED WAS ACTUALLY A CRACK; 2) THE USER DID NOT CONDUCT ALL OF THE PERFORMANCE TESTS PRIOR TO USE AS INSTRUCTED BY THE LABELING, AND 3) THE USER DID NOT INSERT THE LMA USING THE RECOMMENDED TECHNIQUE DETAILED IN THE LABELING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |