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 2020-01-14 for INVISALIGN SYSTEM INVISALIGN SYSTEM - LITE 8852 manufactured by Align Technology, Inc..
[178333397]
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 this event appears to have been potentially serious in nature or life threatening to the patient, and an align product was being used.
Patient Sequence No: 1, Text Type: N, H10
[178333398]
The patient reported symptoms of glottic edema (swollen vocal cords), swollen lips, sore mucosa and burning sensation. The patient reported visiting the emergency room due to the reported symptoms. The patient reported being prescribed anti-allergy medication (unspecified) to alleviate the reported symptoms. The treatment was discontinued on (b)(6) 2019 and the patient is currently getting better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2019-03795 |
| MDR Report Key | 9588943 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-09-06 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| Model Number | INVISALIGN SYSTEM - LITE |
| Catalog Number | 8852 |
| Lot Number | 30949119 |
| 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. Life Threatening | 2020-01-14 |