FDA Adverse Event
Malfunction
Summary report: N
9681900-1997-00027
MDR report key: 118078
·
Received September 4, 1997
Report
- Report Number
- 9681900-1997-00027
- Event Type
- Malfunction
- Date Received
- September 4, 1997
- Product Code
- CAE
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
THE USER FACILITY RETURNED THE LMA IN QUESTION TO THE MFR FOR EVALUATION. THE U.S. DISTRIBUTOR HAS REQUESTED PERMISSION TO CONDUCT AN IN-SERVICE VISIT AT THE USER FACILITY IN RESPONSE TO THE TWO REPORTS OF CONNECTOR BREAKS. A SUPPLEMENTAL MDR WILL BE FILED IF ADD'L INFO IS OBTAINED, OTHERWISE THE FILE WILL BE CONSIDERED CLOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CAE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |