FDA Adverse Event
Death
Summary report: N
NEONATAL TRACHEOSTOMY TUBE
MDR report key: 309797
·
Received December 22, 2000
Report
- Report Number
- 1220850-2000-00001
- Event Type
- Death
- Date Received
- December 22, 2000
- Date of Event
- July 1, 1995
- Report Date
- December 21, 2000
- Manufacturer
- E. BENSON HOOD LABORATORIES, INC.
- Product Code
- BTO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
NOT YET KNOWN. A STATEMENT OF EVENTS HAS BEEN REQUESTED, BUT A REPORT HAS NOT BEEN RECEIVED.
Description of Event or Problem · 1
THE TACHEOSTOMY TUBE ASSOCIATED WITH MDR 1220850-2000-00001 IS THE TUBE REPORTED IN MDR 1220850-1996-00002. THE 11/2000 LETTER ALERTING CO TO THIS EVENT WAS WRITTEN BY AN ATTORNEY. INVESTIGATION INTO THE MATTER REVEALED THE FACT THAT THIS EVENT IS INDEED THE DEVICE REPORTED TO CO IN 1996.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEONATAL TRACHEOSTOMY TUBE | TRACHEOSTOMY TUBE | BTO | E. BENSON HOOD LABORATORIES, INC. | 10035 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Death |