MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-11-09 for STORZ ANDERSON-NEIVERT CURVED RIGHT OSTEOTOME N4366 manufactured by Bausch & Lomb, Inc..
[2356486]
A report from the user facility states that "a tip of instrument half of size of a small fingernail broken off in sinus area and is still embedded in the pt. They needed consent so they did not remove during time of surgery. Needs another surgery to remove. They needed consent so they did not remove during the time of surgery. " add'l info that the pt is undecided as to have the fragment removed. No other info was available.
Patient Sequence No: 1, Text Type: D, B5
[9378061]
The device has not been received for eval at this time. A supplemental report will be filed should the device become available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00176 |
| MDR Report Key | 2335239 |
| Report Source | 06 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-10-19 |
| Date of Event | 2011-10-11 |
| Date Mfgr Received | 2011-10-19 |
| Date Added to Maude | 2011-11-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON TRELFORD, DIR |
| Manufacturer Street | 30 ENTERPRISE, STE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ ANDERSON-NEIVERT CURVED RIGHT OSTEOTOME |
| Generic Name | NONE |
| Product Code | GFI |
| Date Received | 2011-11-09 |
| Model Number | N4366 |
| Catalog Number | N4366 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB, INC. |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-11-09 |