FDA Adverse Event
Injury
Summary report: N
SCT SPECIALIZED TRACH
MDR report key: 2298005
·
Received October 11, 2011
Report
- Report Number
- 2936999-2011-00582
- Event Type
- Injury
- Date Received
- October 11, 2011
- Date of Event
- September 1, 2011
- Report Date
- September 15, 2011
- Manufacturer
- COVIDIEN/ FORMERLY TYCO HE
- Product Code
- JOH
- PMA / PMN Number
- K903435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE CALLING REPORTED THE PT REC'D A CUSTOM TRACHEOSTOMY TUBE WITH AN OBTURATOR THAT WAS 5MM TOO SHORT. THE PT WAS RECANNULATED WITH AN UNSPECIFIED TUBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCT SPECIALIZED TRACH | TRACHEOSTOMY TUBE | JOH | COVIDIEN/ FORMERLY TYCO HE | 1108000484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |