FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 3003864
·
Received March 11, 2013
Report
- Report Number
- 2936999-2013-00179
- Event Type
- Injury
- Date Received
- March 11, 2013
- Date of Event
- January 1, 2013
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K945513
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SAMPLE IS EXPECTED TO BE RETURNED.
Description of Event or Problem · 1
THE CALLER REPORTED WHEN THE MOM WENT TO PUT A NEW TRACH IN THE PT, HE REMOVED THE INTRODUCER AND IT WAS VERY STIFF. THE CALLER REPORTED THAT SHE THEN WENT TO SUCTION THE TRACHEOSTOMY AND FELT THERE WAS A BLOCKAGE IN THE TUBE. THE CALLER REPORTED THAT DECANNULATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CALLER STATED THE PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101693 | SHILEY | PEDIATRIC TRACH TUBE | JOH | COVIDIEN, FORMERLY TYCO HEALTHCARE | 120101342X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |