MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-02 for DENTAL BRACES manufactured by Ormco.
[90974628]
I had braces, and it is very bad effect to my body health and mental health. It destroys my teeth that my teeth and gum looks very ugly. It made me mentally very unstable, and can not study, concentrate, and live by myself. I can not do what i can do before like go to school or eat. The dental braces totally destroyed my healthy life. Can not go to school or study. Very hard to communicate to someone due to destructive mental health. Dates of use: (b)(6) 2014 - (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073087 |
| MDR Report Key | 6995803 |
| Date Received | 2017-11-02 |
| Date of Report | 2017-10-31 |
| Date of Event | 2014-01-31 |
| Date Added to Maude | 2017-11-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DENTAL BRACES |
| Generic Name | ORTHODONTIC BRACKETS |
| Product Code | EJF |
| Date Received | 2017-11-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-11-02 |