MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for SMILE DIRECT CLUB ORTHODONTIC TREATMENT manufactured by Smile Direct Club/align Technology, Inc..
[175827854]
Patients is military member who utilized smile direct club for orthodontic treatment. Upon completion of treatment, patient was seen for dental examination with moderate severe gingival disease and bone loss on teeth with mobility. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092280 |
| MDR Report Key | 9596059 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-10 |
| Date Added to Maude | 2020-01-16 |
| 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 | DENTIST |
| 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 | SMILE DIRECT CLUB ORTHODONTIC TREATMENT |
| Generic Name | ALIGNER SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-01-15 |
| Device Availability | N |
| 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 | 2020-01-15 |