MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-03-08 for ONE STEP CANNULA 58.25S manufactured by Synergetics.
[17560911]
Surgeon complained of metal shavings around the pt's eye after using the product. It is not clear what instruments the surgeon used during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932402-2012-00002 |
| MDR Report Key | 2708789 |
| Report Source | 07 |
| Date Received | 2012-03-08 |
| Date of Report | 2012-03-08 |
| Date of Event | 2012-02-08 |
| Date Mfgr Received | 2012-02-08 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-08-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN REGAN |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal | 63368 |
| Manufacturer Phone | 6367945013 |
| Manufacturer G1 | SYNERGETICS, INC. |
| Manufacturer Street | 3845 CORPORATE CENTRE DR. |
| Manufacturer City | O'FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONE STEP CANNULA |
| Generic Name | CANNULA |
| Product Code | HQB |
| Date Received | 2012-03-08 |
| Model Number | 58.25S |
| Catalog Number | 58.25S |
| Lot Number | M031370 |
| Device Expiration Date | 2014-12-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS |
| Manufacturer Address | 3845 CORPORATE CENTRE DR. O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-08 |