MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-11-05 for INVISALIGN SYSTEM, SEQUENTIAL ALIGNER manufactured by Align Technology.
[705608]
The pt experienced swelling of her throat, mouth, and eyes while wearing aligners. The orthodontist reported three possible causes of the symptoms as allergic reaction, lupus, or hereditary angioedema. Further evaluation associated the symptoms more to a rare form of hereditary angioedema. The treating orthodontist and the pt had been unaware of the pre-existing hereditary angioedema. The device was removed and the pt discontinued orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
[7896787]
Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953749-2007-00001 |
| MDR Report Key | 938420 |
| Report Source | 05 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-10-03 |
| Date of Event | 2007-04-25 |
| Date Mfgr Received | 2007-10-03 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2008-01-02 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM, SEQUENTIAL ALIGNER |
| Generic Name | ORTHODONTIC APPLIANCE |
| Product Code | KMY |
| Date Received | 2007-11-05 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 935362 |
| Manufacturer | ALIGN TECHNOLOGY |
| Manufacturer Address | 851 MARTIN AVE SANTA CLARA CA 95050 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-11-05 |