MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-13 for ENLIGHT 740-0198 manufactured by Ormco Corporation.
[4875240]
A doctor alleged that multiple patients had experienced the enlight bracket bonding material turning brown around the edges of the brackets and the slight decalcification of teeth.
Patient Sequence No: 1, Text Type: D, B5
[12419048]
Specific information with regard to the exact number of patients affected, genders, ages, and weights was not provided. The doctor removed and replaced the brackets for each of the patients. To date, each of the patients are doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no further evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00486 |
| MDR Report Key | 4167014 |
| Report Source | 05 |
| Date Received | 2014-10-13 |
| Date of Report | 2014-09-22 |
| Date Mfgr Received | 2014-09-22 |
| Date Added to Maude | 2014-10-14 |
| 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 | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| 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 | ENLIGHT |
| Generic Name | BRACKET ADHESIVE |
| Product Code | DYH |
| Date Received | 2014-10-13 |
| Catalog Number | 740-0198 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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; 2. Required No Informationntervention | 2014-10-13 |