MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for VIVERA RETAINER manufactured by Align Technology, Inc..
[105212953]
It has happened every time i use my vivera tray from invisalign. My tongue and throat feel irritated and i have a bad cough for a few days. I kept associating it with my seasonal allergies but have ruled that out as i always feel fine before putting the trays in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076381 |
| MDR Report Key | 7411264 |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-04-05 |
| Date Added to Maude | 2018-04-10 |
| 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 | 0 |
| Brand Name | VIVERA RETAINER |
| Generic Name | MAINTAINER, SPACE PREFORMED |
| Product Code | DYT |
| Date Received | 2018-04-09 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-04-09 |