FDA Adverse Event
Injury
Summary report: N
INTER HI-LO 7.5MM
MDR report key: 1583399
·
Received January 20, 2010
Report
- Report Number
- 2936999-2009-01234
- Event Type
- Injury
- Date Received
- January 20, 2010
- Date of Event
- November 1, 2009
- Report Date
- December 21, 2009
- Manufacturer
- COVIDIEN/FORMERLY TYCO HEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K965132
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RETURN OF THE TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION WAS REQUESTED.
Description of Event or Problem · 1
THE CALLER REPORTED SOMETIME DURING THE PAST TWO MONTHS, THEY EXPERIENCED DIFFICULTY WITH SECRETIONS STICKING TO THE SIDES OF THE ENDOTRACHEAL TUBE AND ABOVE AND BELOW THE CUFF, AND INTERNALLY. THE PATIENT REQUIRED A NON-ROUTINE REPLACEMENT OF THE TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTER HI-LO 7.5MM | ENDOTRACHEAL TUBE | BTR | COVIDIEN/FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |