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 2020-02-26 for INVISALIGN SYSTEM INVISALIGN GO 8596 manufactured by Align Technology, Inc..
| Report Number | 2953749-2020-00360 |
| MDR Report Key | 9759543 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-26 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7891588 |
| 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 | 2020-02-26 |
| Model Number | INVISALIGN GO |
| Catalog Number | 8596 |
| Lot Number | 32931147 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2020-02-26 |