MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-17 for SYSTEM 1+ ACTIVATOR manufactured by Ormco Corporation.
[15445420]
On august 18, 2009, ormco corporation received a complaint from a doctor stating that several days after application of system 1+ activator, the patient developed yellow staining on his teeth.
Patient Sequence No: 1, Text Type: D, B5
[15660382]
Doctor's office was contacted, and it was confirmed that the doctor was unable to remove yellow staining from the patient's teeth. The doctor feels that the staining is permanent, as there has been no change in the patient's teeth in the past four weeks. The product was returned for evaluation, but evaluation results have not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2009-00074 |
| MDR Report Key | 1475524 |
| Report Source | 05 |
| Date Received | 2009-09-17 |
| Date of Report | 2009-08-18 |
| Date Mfgr Received | 2009-08-18 |
| Date Added to Maude | 2009-09-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| 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 | SYSTEM 1+ ACTIVATOR |
| Generic Name | BRACKET ADHESIVE |
| Product Code | DYH |
| Date Received | 2009-09-17 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-09-17 |