MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-08-18 for UNK manufactured by Unk.
[1352655]
During a cataract extraction, the surgeon noted that the tip of the nagahara chopper was missing. The eye was inspected under the microscope and an xray was taken, the object was not found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1812664 |
| MDR Report Key | 1812664 |
| Report Source | 99 |
| Date Received | 2010-08-18 |
| Date of Report | 2010-08-16 |
| Date of Event | 2010-07-22 |
| Date Facility Aware | 2010-07-22 |
| Report Date | 2010-08-16 |
| Date Added to Maude | 2010-08-26 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | NAGAHARA CHOPPER |
| Product Code | HNQ |
| Date Received | 2010-08-18 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-18 |