MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-13 for INVISALIGN manufactured by Align Technology.
[89560887]
Started invisalign dental correction in (b)(6) 2017 and developed side effects of burning tongue, swollen face, bloody nose, red eyes and extreme fatigue. Got worse the longer i wore the retainers. Took a four week break and within a week all symptoms were gone. Initiated treatment again wearing the retainer in a "hypoallergenic" formula and symptoms were back immediately. Align technology is the manufacturing company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072754 |
| MDR Report Key | 6950936 |
| Date Received | 2017-10-13 |
| Date of Report | 2017-10-11 |
| Date of Event | 2017-07-01 |
| Date Added to Maude | 2017-10-16 |
| 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 | 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 | INVISALIGN |
| Generic Name | MANITAINER, SPACE PERFORMED, ORTHODONTIC |
| Product Code | DYT |
| Date Received | 2017-10-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-13 |