MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-05-20 for AIR INJECTION CANNULA E0499 30 manufactured by Bausch & Lomb.
[17372705]
The irrigating cannula broke in two pieces during a procedure. Both pieces were found before the end of the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920664-2010-00148 |
| MDR Report Key | 1698665 |
| Report Source | 06 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-02-16 |
| Date of Event | 2010-01-27 |
| Report Date | 2010-02-01 |
| Date Reported to FDA | 2010-02-01 |
| Date Mfgr Received | 2010-04-22 |
| Date Added to Maude | 2010-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263213 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR INJECTION CANNULA |
| Generic Name | OPHTHALMIC CANNULA |
| Product Code | FGY |
| Date Received | 2010-05-20 |
| Model Number | NA |
| Catalog Number | E0499 30 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-20 |