FDA Adverse Event
Injury
Summary report: N
SHILEY SCT SPECIALIZED
MDR report key: 1587230
·
Received January 21, 2010
Report
- Report Number
- 2936999-2009-01244
- Event Type
- Injury
- Date Received
- January 21, 2010
- Date of Event
- December 1, 2009
- Report Date
- December 23, 2009
- Manufacturer
- COVIDIEN/ FORMERLY TYCO HEALTHCARE
- Product Code
- BTO
- PMA / PMN Number
- K810106
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION WAS REQUESTED.
Description of Event or Problem · 1
THE CALLER REPORTED THE TUBE WAS PLACED IN THE PT FOR TWO WEEKS AND THEN REMOVED FOR TWO WEEKS AND THEN REPLACED IN THE PT FOR ONE WEEK AT WHICH TIME IT THEN FAILED TO HOLD AIR. A NON-ROUTINE REPLACEMENT OF THE TUBE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY SCT SPECIALIZED | TRACHEOSTOMY TUBE | BTO | COVIDIEN/ FORMERLY TYCO HEALTHCARE | 0909001967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |