FDA Adverse Event
Injury
Summary report: N
MALLINCKRODT
MDR report key: 1935976
·
Received December 9, 2010
Report
- Report Number
- 2936999-2010-01354
- Event Type
- Injury
- Date Received
- December 9, 2010
- Date of Event
- October 1, 2010
- Report Date
- November 9, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTR
- PMA / PMN Number
- K791045
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IS NOT DISTRIBUTED IN THE US; HOWEVER IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. APPLICABLE 510K# FOR US 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 REC'D A REPORT WHERE IT WAS CLAIMED THAT THE PILOT BALLOON DEVELOPED A LEAK DURING PT USE. THE END CLINICIAN ELECTED TO EXTUBATE AND REINTUBATE WITH A REPLACEMENT TUBE. NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINCKRODT | HI-LO TRACHEAL TUBE WITH LANZ | BTR | COVIDIEN, FORMERLY TYCOHEALTHCARE | 2010071348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |