MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for SMILE DIRECT CLUB manufactured by Smile Direct Club / Align Technology, Inc..
[182531157]
Pt started using clear aligner from smile direct club without informing dentist of record. No dentist supervision at smile direct club, no doctor okayed case. A week later, using aligner had fractured off a large filling in front tooth. Pt came in to her dentist of record and had tooth repaired. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093538 |
| MDR Report Key | 9793379 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-03-02 |
| Date of Event | 2019-07-01 |
| Date Added to Maude | 2020-03-05 |
| 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 |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-03-04 |
| Operator | LAY USER/PATIENT |
| 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. Required No Informationntervention | 2020-03-04 |