MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for BRACES (DAMON CERAMIC BRACES) manufactured by Ormco Corporation.
[90896782]
I had braces. I thought braces was safe, but it totally made my bite bad, and made my whole teeth alignment looks ugly. I think it made my mind so unstable. Cannot concentrate at all. I want fda to ban the braces. It is dangerous. It stole the healthy life from me.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073068 |
| MDR Report Key | 6993510 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-10-28 |
| Date of Event | 2014-02-01 |
| Date Added to Maude | 2017-11-01 |
| 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 | BRACES (DAMON CERAMIC BRACES) |
| Generic Name | ORTHODONTIC CERAMIC BRACKETS |
| Product Code | NJM |
| Date Received | 2017-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |