FDA Adverse Event
Death
Summary report: N
UNSPECIFIED ETT
MDR report key: 1373629
·
Received April 30, 2009
Report
- Report Number
- 2936999-2009-00250
- Event Type
- Death
- Date Received
- April 30, 2009
- Date of Event
- April 2, 2007
- Report Date
- April 21, 2009
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE TUBE IS NOT AVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNKNOWN. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER.
Description of Event or Problem · 1
INFORMATION WAS REPORTED ON 04/21/2009 REGARDING AN INCIDENT WHICH ALLEGEDLY INVOLVED AN UNSPECIFIED MALLINCKRODT ENDOTRACHEAL TUBE. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED IN 2006, UNDERWENT A BRONCHOSCOPY SIX DAYS LATER AND DIED IN 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNSPECIFIED ETT | NONE | BTR | COVIDIEN, FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |