MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-01 for INVISALIGN SYSTEM manufactured by Align Technology.
[495113]
Pt, while using the third set of the aligners, experienced an allergic reaction in the form of swollen tongue which created difficulty in her breathing. The device was removed and the pt discontinued invisalign treatment. She did not have a known reaction to the first two aligners. The pt is now being treated using wires and brackets (braces). The treating orthodontist reported that the pt is experiencing some tongue discomfort with wires and brackets but generally she is tolerating her treatment well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2006-00001 |
| MDR Report Key | 757050 |
| Report Source | 05 |
| Date Received | 2006-09-01 |
| Date of Report | 2006-08-03 |
| Date of Event | 2006-08-03 |
| Date Mfgr Received | 2006-08-03 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2006-09-06 |
| 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 | 0 |
| Manufacturer Contact | SHEIDA TOUSSI |
| Manufacturer Street | 881 MARTIN AVE |
| Manufacturer City | SANTA CLARA CA 95050 |
| Manufacturer Country | US |
| Manufacturer Postal | 95050 |
| Manufacturer Phone | 4084701440 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ORTHODONTIC APPLIANCE |
| Product Code | KMY |
| Date Received | 2006-09-01 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 744953 |
| Manufacturer | ALIGN TECHNOLOGY |
| Manufacturer Address | 851 MARTIN AVE SANTA CLARA CA 95050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-01 |