FDA Adverse Event
Malfunction
Summary report: N
YANKAUER BULB RIGID W/O TROL
MDR report key: 1942391
·
Received December 23, 2010
Report
- Report Number
- 9612030-2010-00034
- Event Type
- Malfunction
- Date Received
- December 23, 2010
- Report Date
- November 18, 2010
- Manufacturer
- COVIDIEN
- Product Code
- JOL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE (B)(4) 2010. AN INVESTIGATION IS UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A YANKAUER. THE CUSTOMER REPORTED THAT THE YANKAUER BROKE PRIOR TO THE CURVATURE AFTER PLACING THE YANKAUER UNDER THE PT'S PILLOW IN THE RECOVERY ROOM IN PREPARATION FOR EXTUBATION. NOT USED ON PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | YANKAUER BULB RIGID W/O TROL | YANKAUER | JOL | COVIDIEN | 8888505016 | 020125964 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |