MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-11 for ALIGNERS FOR TEETH 100-0352 manufactured by Smile Direct Club / Align Technology, Inc..
[179314331]
Over a course of 1. 5 years i had aligners sent to me from smile direct club. I made it halfway through the initial 6 months and then the aligners wouldn't stay on my teeth. The club responded after i sent more pictures and 6 months later set me a 3 month course of action. I was able to use the aligners for 6 weeks and then again the aligners wouldn't fit. Again, i had a scan done at the local smile direct shop. After another 4 months i was again sent aligners for 6 months. The very first aligner wouldn't fit and so i went to the local smile shop and they agreed they would never fit. Now, 1. 5 years later my teeth are in worse shape than when i started. One of my teeth aches. I will have to see a local orthodontist and pay much more than i would have if i had never seen the advertisements for the smile direct club. They are a scam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092941 |
| MDR Report Key | 9699720 |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-29 |
| Date of Event | 2018-07-18 |
| Date Added to Maude | 2020-02-12 |
| 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 FOR TEETH |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-02-11 |
| Model Number | 100-0352 |
| Device Availability | * |
| 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. Other | 2020-02-11 |