FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1961052
·
Received January 11, 2011
Report
- Report Number
- 2936999-2011-00015
- Event Type
- Injury
- Date Received
- January 11, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 13, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IS NOT DISTRIBUTED IN THE UNITED STATES; HOWEVER, IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE UNITED STATES. APPLICABLE 510K# FOR UNITED STATES DISTRIBUTED PART IS K791045. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MANUFACTURING SITE FOR ANALYSIS. IF SIGNIFICANT INFORMATION 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 COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE CUFF DEVELOPED A LEAK DURING PATIENT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | HI-LO TRACHEAL TUBE WITH LANZ | BTR | COVIDIEN, FORMERLY TYCOHEALTHCARE | 2008108974 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |