MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for ALIGNERS manufactured by Smile Direct Club / Align Technology, Inc..
[181381998]
Sdc aligners were not fitting and were causing tmj problems. The only help i am getting is to keep going it will get better. Well it hasn't. My teeth have not straightened and i have no bite. It is hard to chew as my jaw hurts. I have gotten 2 sets of aligners but there is no difference. This online orthodontist is a scam and i am angry i fell for it. This dentist must stop. I am going to see a real orthodontist in person as something has to be done to correct this mess. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093287 |
| MDR Report Key | 9753845 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-22 |
| Date of Event | 2019-09-01 |
| Date Added to Maude | 2020-02-26 |
| 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 | 3 |
| Brand Name | ALIGNERS |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-02-25 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMILE DIRECT CLUB / ALIGN TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-25 |