FDA Adverse Event
Injury
Summary report: N
SHILEY DISPOSABLE CANNULA LOW PRESSURE
MDR report key: 2030448
·
Received March 18, 2011
Report
- Report Number
- 2936999-2011-00210
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 22, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K962173
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. THE SAMPLE RELATED TO THIS REPORT IS CURRENTLY IN TRANSIT AND ANTICIPATED FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE TRACHEOSTOMY TUBE'S CUFF WOULD NOT REMAIN INFLATED. THE TUBE WAS REMOVED AND THE PT WAS RECANNULATED WITH A NEW UNSPECIFIED MODEL OF TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY DISPOSABLE CANNULA LOW PRESSURE | TRACHEOSTOMY TUBE | JOH | COVIDIEN, FORMERLY TYCO HEALTHCARE | 0803002168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |