MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-21 for SNAPPER A63002 manufactured by Akorn.
[17024742]
Surgeon was using snapper instrument during cataract surgeon when tip broke off against hard nucleus in pt's eye. Surgeon removed tip with kellman forcep with no injury to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023713 |
| MDR Report Key | 369153 |
| Date Received | 2001-12-21 |
| Date of Report | 2001-12-13 |
| Date of Event | 2001-12-13 |
| Date Added to Maude | 2002-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SNAPPER |
| Generic Name | NUCLEUS CHOPPER |
| Product Code | HNQ |
| Date Received | 2001-12-21 |
| Model Number | A63002 |
| Catalog Number | A63002 |
| Lot Number | NA |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 358269 |
| Manufacturer | AKORN |
| Manufacturer Address | 2500 MILLBROOK DR BUFFALO GROVE IL 60089 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-12-21 |