MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-29 for INVISALIGN SYSTEM INVISALIGN SYSTEM - COMPREHENSIVE 8812 manufactured by Align Technology, Inc..
[176958363]
No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms. This event is being filed as an mdr as the patient reported the symptom of chest pain and an align product was being used.
Patient Sequence No: 1, Text Type: N, H10
[176958364]
The patient reported symptoms of breathing problems, dryness of mouth and chest pain. The patient did not require any medical intervention to alleviate the reported symptoms. The patient did not report taking or being prescribed any medication to alleviate the reported symptoms. The treatment was discontinued approximately on (b)(6) 2019. The treating doctor reported the potential root cause of the event is a chest infection due to an allergy to the aligners.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2020-00021 |
| MDR Report Key | 9645150 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2019-09-10 |
| Date Added to Maude | 2020-01-29 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN HOFFMEISTER |
| Manufacturer Street | 2820 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4087891588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-01-29 |
| Model Number | INVISALIGN SYSTEM - COMPREHENSIVE |
| Catalog Number | 8812 |
| Lot Number | 30778831 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY, INC. |
| Manufacturer Address | 2820 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-29 |