FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 3060305
·
Received April 11, 2013
Report
- Report Number
- 2936999-2013-00277
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 15, 2013
- Manufacturer
- COVIDIEN / FORMERLY TYCOHEA.
- Product Code
- JOH
- PMA / PMN Number
- K945513
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE AVAILABLE FOR ANALYSIS. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE CURVE OF THE CANNULA WAS INCORRECT, SO THEY COULD NOT INTRODUCE IT IN THE PATIENT. THE END USER USED AN OTHER CANNULA. THE INFORMATION TO DATE SUGGEST THAT THE ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS RELATED TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154303 | SHILEY | PEDIATRIC TRACH TUBE | JOH | COVIDIEN / FORMERLY TYCOHEA. | 120300598X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |