FDA Adverse Event
Malfunction
Summary report: N
DIC TRACHEOSTOMY TUBE, FENESTRATED
MDR report key: 63833
·
Received January 15, 1997
Report
- Report Number
- 1217052-1997-00004
- Event Type
- Malfunction
- Date Received
- January 15, 1997
- Date of Event
- December 4, 1996
- Report Date
- December 16, 1996
- Manufacturer
- SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
- Product Code
- BTO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THIS FOLLOW-UP CONSISTS OF AN UPDATE TO A.4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIC TRACHEOSTOMY TUBE, FENESTRATED | TRACHEOSTOMY TUBE AND TUBE CUFF | BTO | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | NA | 608111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |