MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-17 for BRACKET, METAL, ORTHODONTIC manufactured by Ormco Corporation.
[92466562]
Ormco corporation was notified by the department of health and human services that a complaint had been registered with regard to the alleged serious injury. Specific patient information was not provided; therefore we are unable to receive further information. The product involved in this incident was not returned therefore no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[92466563]
It was alleged that the orthodontic brackets made the patient mentally unstable and experienced damage to their teeth and gums.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2017-00006 |
| MDR Report Key | 7043229 |
| Date Received | 2017-11-17 |
| Date of Report | 2017-11-14 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2017-11-14 |
| Date Added to Maude | 2017-11-17 |
| 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 | 3 |
| Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | BRACKET, METAL, ORTHODONTIC |
| Product Code | EJF |
| Date Received | 2017-11-17 |
| 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 AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2017-11-17 |