MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-14 for SMYLIO (ORTHOFX) CLEAR ALIGNERS N/A manufactured by Smylio.
| Report Number | 3015143007-2020-00001 |
| MDR Report Key | 9713877 |
| Report Source | CONSUMER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-11-05 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BILL JACQMEIN |
| Manufacturer Street | 48890 MILMONT DRIVE |
| Manufacturer City | FREMONT, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2166190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMYLIO (ORTHOFX) CLEAR ALIGNERS |
| Generic Name | CLEAR ALIGNERS |
| Product Code | NXC |
| Date Received | 2020-02-14 |
| Model Number | CLEAR ALIGNER |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMYLIO |
| Manufacturer Address | 48890 MILMONT DRIVE FREMONT, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |