MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,02 report with the FDA on 2004-06-22 for * manufactured by *.
| Report Number | 9614761-2004-00004 |
| MDR Report Key | 531782 |
| Report Source | 00,02 |
| Date Received | 2004-06-22 |
| Date of Event | 2004-04-08 |
| Date Added to Maude | 2004-06-30 |
| 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 | 3 |
| 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 |
| Brand Name | * |
| Generic Name | * |
| Product Code | MWL |
| Date Received | 2004-06-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 521030 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-22 |