MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-06 for INVISALIGN manufactured by Align Technologies.
[94353597]
On (b)(6) 2017, invisalign along with buttons replaced in my mouth both top and bottom. That same evening i developed a stuffy nose and severe sore throat. And fortunately have a shellfish allergy, latex and celiac disease, therefore i am very familiar that's what anaphylactic feels like. As the days progress my throat continues to swell more my speech became harsh and i felt symptoms of anaphylactic period on thursday and i contacted invisalign and m dentist to make them aware of the situation. We decided to remove the trays yet the symptoms still resided. We've been scheduled to remove the buttons which just for removal on (b)(6). I had emailed my dentist throughout the weekend prior to the removal of the buttons letting her know my concerns regarding the allergy. I would like to further investigated as and many other pts that suffer the same allergy from invisalign and the buttons. I am not sure what ingredient is causing this reaction to many of us but it does need to be deeply investigated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073817 |
| MDR Report Key | 7095843 |
| Date Received | 2017-12-06 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-11-28 |
| Date Added to Maude | 2017-12-07 |
| 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, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2017-12-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGIES |
| Brand Name | BUTTON |
| Generic Name | BRACKET, PLASTIC, ORTHODONTIC |
| Product Code | DYW |
| Date Received | 2017-12-06 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-06 |