MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-15 for IRIS RETRACTORS 40.02-6 * manufactured by Synergetics, Inc..
[1649160]
Two iris retractors broke inside the eye when the surgeon was putting it in. He was using this to open the pupil. The surgeon states he was able to retrieve all the broken pieces. The surgeon spoke with the manufacturer about this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1913119 |
| MDR Report Key | 1913119 |
| Date Received | 2010-11-15 |
| Date of Report | 2010-11-15 |
| Date of Event | 2010-11-02 |
| Report Date | 2010-11-15 |
| Date Reported to FDA | 2010-11-15 |
| Date Added to Maude | 2010-12-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRIS RETRACTORS |
| Generic Name | DISPOSABLE FLEXIBLE IRIS RETRACTOR |
| Product Code | HNI |
| Date Received | 2010-11-15 |
| Model Number | 40.02-6 |
| Catalog Number | * |
| Lot Number | 9010411 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS, INC. |
| Manufacturer Address | 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-15 |