FDA Adverse Event
Malfunction
Summary report: N
AIR INJECTION CANNULA
MDR report key: 1698665
·
Received May 20, 2010
Report
- Report Number
- 1920664-2010-00148
- Event Type
- Malfunction
- Date Received
- May 20, 2010
- Date of Event
- January 27, 2010
- Report Date
- February 16, 2010
- Manufacturer
- BAUSCH & LOMB
- Product Code
- FGY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE IRRIGATING CANNULA BROKE IN TWO PIECES DURING A PROCEDURE. BOTH PIECES WERE FOUND BEFORE THE END OF THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIR INJECTION CANNULA | OPHTHALMIC CANNULA | FGY | BAUSCH & LOMB | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |