MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-09 for STORZ ANDERSON-NIEVERT CURVED RIGHT OSTEOTOME N4367 manufactured by Bausch & Lomb, Inc..
[2356929]
A report from the user facility states that "this event took place in (b)(6) 2009 the ent specialist performed a septal rhinoplasty, as the pt had a deviated septum. After the procedure when the doctor removed the osteotome she noticed the tip had broken off. They took an x-ray and saw the tip was embedded in the pt's sinus. The tip is still in the pt and it is considered high-risk to remove it because they have to perform external surgery. No other info was available. " add'l info: the pt declined the second surgery.
Patient Sequence No: 1, Text Type: D, B5
[9386176]
The device has not been received for eval at this time, though requested. A supplemental report will be filed should the device become available for investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00183 |
| MDR Report Key | 2335261 |
| Report Source | 05,06 |
| Date Received | 2011-11-09 |
| Date of Report | 2011-10-19 |
| Date of Event | 2009-07-29 |
| 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-NIEVERT CURVED RIGHT OSTEOTOME |
| Generic Name | NONE |
| Product Code | GFI |
| Date Received | 2011-11-09 |
| Model Number | N4367 |
| Catalog Number | N4367 |
| 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 |