FDA Adverse Event
Injury
Summary report: N
SHILEY DISPOSABLE CANNULA LOW PRESSURE
MDR report key: 2030494
·
Received March 18, 2011
Report
- Report Number
- 2936999-2011-00135
- Event Type
- Injury
- Date Received
- March 18, 2011
- Date of Event
- January 1, 2010
- Report Date
- February 18, 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
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER IS UNK, THEREFORE, THE DATE OF MANUFACTURE CAN NOT BE DETERMINED.
Description of Event or Problem · 1
COVIDIEN RECEIVED A LETTER DATED (B)(6) 2011 WHICH ALLEGED A PT TREATED AT JOHNS HOPKINS BAYVIEW MEDICAL CENTER SUFFERED SERIOUS INJURY ON TWO OCCASIONS. THE LETTER ALLEGES THE PT'S INJURIES OCCURRED AS A RESULT OF TWO SHILEY 8DCT TRACHEOSTOMY TUBES. ONE OCCASION WAS REPORTED AS OCCURRING IN EARLY (B)(6) 2010. THE FIRST TUBE AND INJURY IS REPORTED ON RELATED REPORT NUMBER 2936999-2011-00132.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY DISPOSABLE CANNULA LOW PRESSURE | TRACHEOSTOMY TUBE | JOH | COVIDIEN FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |