MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-08-19 for ORTHO SOLO 740-0269 manufactured by Ormco Corp..
| Report Number | 2016150-2004-00002 |
| MDR Report Key | 886486 |
| Report Source | 05,07 |
| Date Received | 2004-08-19 |
| Date of Report | 2004-07-20 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-07-20 |
| Date Added to Maude | 2007-07-31 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | WENDY URTEL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167425 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHO SOLO |
| Generic Name | SEALER AND BOND ENHANCER |
| Product Code | EBC |
| Date Received | 2004-08-19 |
| Model Number | NA |
| Catalog Number | 740-0269 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 864221 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-19 |