MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-23 for UNK manufactured by .
[4939474]
Reporter stated that her son had metal dental braces with sliding wires applied due to his overbite and crossbite on (b)(6), 2014. On (b)(6), 2014 she stated that her son complained of pain and a clicking/popping sound in his jaw. She took him to the orthodontist to be evaluated and she decided to have them removed on (b)(6), 2014. She was concerned that these symptoms may be related to tmd/tmj and wanted to make the fda aware for statistical purposes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038302 |
| MDR Report Key | 4114564 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-09-23 |
| Date of Event | 2014-09-09 |
| Date Added to Maude | 2014-09-25 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | METAL DENTAL BRACES WITH SLIDING WIRES |
| Product Code | NQS |
| Date Received | 2014-09-23 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-23 |