MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-02 for INVISALIGN SYSTEM VIVERA RETAINER 8579 manufactured by Align Technology, Inc..
[96210278]
No test methods have been performed as the product performed in accordance to specifications and the device was used in accordance with labeled indications. No conclusive evidence has been provided that supports or opposes that fact that the vivera retainers caused or contributed to the patients symptoms. This event is being filed as an mdr since the treating doctor considered the event was serious and life threatening to the patient and the invisalign product was being used at that time.
Patient Sequence No: 1, Text Type: N, H10
[96210279]
The patient reported symptoms of anaphylactic episode and vomiting. The patients mother reported calling 911 and driving the patient to the er, due to the reported symptoms. The patient reported being given two epipen shots (first on the drive to the er and the second in the er), both given by the patients mother, to alleviate the reported symptoms. The treatment was discontinued on (b)(6) 2017 and the patient is currently back to normal. The treating doctor considered the event was serious and life threatening to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2017-02017 |
| MDR Report Key | 7158683 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-02 |
| Date of Report | 2018-01-02 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2017-12-15 |
| Device Manufacturer Date | 2017-12-09 |
| Date Added to Maude | 2018-01-02 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | MAINTAINER, SPACE PREFORMED |
| Product Code | DYT |
| Date Received | 2018-01-02 |
| Model Number | VIVERA RETAINER |
| Catalog Number | 8579 |
| Lot Number | 23854946 |
| 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. Other | 2018-01-02 |