MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02 report with the FDA on 2003-12-16 for manufactured by .
| Report Number | 9614761-2003-00001 |
| MDR Report Key | 502200 |
| Report Source | 00,02 |
| Date Received | 2003-12-16 |
| Date of Event | 2003-05-22 |
| Date Mfgr Received | 2003-10-17 |
| Date Added to Maude | 2003-12-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1840 GATEWAY DR, 2ND FLOOR |
| Manufacturer City | SAN MATEO CA 94404 |
| Manufacturer Country | US |
| Manufacturer Postal | 94404 |
| Manufacturer Phone | 6503781424 |
| Manufacturer G1 | MENICON CO., LTD. |
| Manufacturer Street | 21-19 AOI 3-CHOME, NAKA-KU |
| Manufacturer City | NAGOYA, AICHI 460-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 460-0006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MWL |
| Date Received | 2003-12-16 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 490968 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-12-16 |