MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-10-28 for * manufactured by *.
| Report Number | 8031673-2004-00009 |
| MDR Report Key | 553324 |
| Report Source | 05,06 |
| Date Received | 2004-10-28 |
| Date of Event | 2004-02-17 |
| Date Mfgr Received | 2004-02-27 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2004-11-05 |
| 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 Contact | LOIS NAKAYAMA |
| Manufacturer Street | 347 OYSTER POINT BLVD. SUITE 201 |
| Manufacturer City | SOUTH SAN FRANCISCO CA 94080 |
| Manufacturer Country | US |
| Manufacturer Postal | 94080 |
| Manufacturer Phone | 8002486764 |
| Manufacturer G1 | TOSOH HI-TECH |
| Manufacturer Street | 4560, KAISEI-CHO, SHIN-NANYO |
| Manufacturer City | YAMAGUCHI 746-8501 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 746-8501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | JHY |
| Date Received | 2004-10-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 542913 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-28 |