MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-24 for DAMON Q 491-6590 manufactured by Ormco Corporation.
[22264598]
An orthodontic office reported that it was alleged by a dentist that a patient had dislodged a damon q bracket and there were signs of enamel damage upon removal.
Patient Sequence No: 1, Text Type: D, B5
[22308854]
It was reported by the orthodontic office that the dentist had removed the loose bracket and filled in the damaged area of the enamel. The date of the repair and product used was unknown by the reporting orthodontic office. To date, the patient is doing fine. The product involved in the alleged incident was not returned and no lot number was provided; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2014-00008 |
| MDR Report Key | 3640809 |
| Report Source | 05 |
| Date Received | 2014-02-24 |
| Date of Report | 2014-01-29 |
| Date Mfgr Received | 2014-01-29 |
| Date Added to Maude | 2014-02-24 |
| 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 | DAMON Q |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2014-02-24 |
| Catalog Number | 491-6590 |
| 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 | 2014-02-24 |