FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 2010813
·
Received March 2, 2011
Report
- Report Number
- 2936999-2011-00153
- Event Type
- Injury
- Date Received
- March 2, 2011
- Date of Event
- January 19, 2011
- Report Date
- February 2, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- JOH
- PMA / PMN Number
- K051416
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE CUSTOMER DID PROVIDE A LOT#. MFG WILL PERFORM A LOT HISTORY REVIEW OF THE REPORTED LOT AS PART OF THE INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE LOT REVIEW THEN A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT OF A LEAKAGE FROM THE CUFF DURING PT USE. THE CALLER REPORTED THE PRODUCT WAS IMPLANTED ON (B)(6), 2010 AND USED UNTIL (B)(6), 2011. THE CANNULA WAS CHANGED IN EMERGENCY DEPARTMENT WITH A NEW ONE. INFO PROVIDED CONFIRMS THAT THE PRODUCT WAS BEING USED BEYOND THE RECOMMENDED 29 DAYS AS STATED IN THE INSTRUCTIONS FOR USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY | SHILEY TRACHEOSOFT XLT | JOH | COVIDIEN, FORMERLY TYCO HEALTHCARE | 2010017749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |