MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-12-26 for manufactured by Asahi Optical Co. Ltd..
| Report Number | 9610877-1996-00008 |
| MDR Report Key | 60345 |
| Report Source | 05,06 |
| Date Received | 1996-12-26 |
| Date of Event | 1996-11-13 |
| Date Mfgr Received | 1996-11-26 |
| Device Manufacturer Date | 1991-04-01 |
| Date Added to Maude | 1997-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GDB |
| Date Received | 1996-12-26 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 51645 |
| Manufacturer | ASAHI OPTICAL CO. LTD. |
| Manufacturer Address | 36-9 MAENO-CHO 2 CHOME ITABASHI-KU TOKYO JA 174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-26 |