MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for INVISALIGN manufactured by Align Technology Inc..
[115598561]
First time of invisalign. Within hours of insertion of my 1st tray by my orthodontist, i had a bad adverse reaction. Swollen, burning and tingling of throat, tongue, soft palate and lips. Felt like throat was closing. Difficulty swallowing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078682 |
| MDR Report Key | 7731208 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-26 |
| Date of Event | 2018-07-23 |
| Date Added to Maude | 2018-07-30 |
| 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 | ALIGNER |
| Product Code | ECQ |
| Date Received | 2018-07-27 |
| 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 | 2018-07-27 |