MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-12 for INVISALIGN SYSTEM manufactured by Align Technology.
[366003]
This incident occurred in the morning. After taking out aligner (clear plastic appliance designed to move teeth to correct malocclusion) and brushing teeth, the pt experienced symptoms that were consistent with a systemic reaction. The symptoms included dizziness, shortness of breath, and chest pain. Pt called 911 and was taken to a hosp, where pt was given benadryl, tagamet, and decadron to stabilize their condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2004-00001 |
| MDR Report Key | 511771 |
| Report Source | 05 |
| Date Received | 2004-02-12 |
| Date of Report | 2004-02-12 |
| Date of Event | 2003-11-18 |
| Date Mfgr Received | 2004-01-20 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2004-02-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ANAR KOTADIA |
| Manufacturer Street | 881 MARTIN AVE |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal | 95050 |
| Manufacturer Phone | 4084701455 |
| Manufacturer G1 | ALIGN TECHNOLOGY |
| Manufacturer Street | 881 MARTIN AVE |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ORTHODONIC APPLIANCE |
| Product Code | KMY |
| Date Received | 2004-02-12 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 500759 |
| Manufacturer | ALIGN TECHNOLOGY |
| Manufacturer Address | 881 MARTIN AVE. SANTA CLARA CA 95050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2004-02-12 |