MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
| Report Number | 3007683266-2020-00010 |
| MDR Report Key | 9863164 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date Mfgr Received | 2020-03-13 |
| Date Added to Maude | 2020-03-20 |
| 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 | HELENE SPENCER |
| Manufacturer Street | 201 TECHNOLOGY |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6009650130 |
| Manufacturer G1 | IVANITS, INC. |
| Manufacturer Street | 38 DISCOVERY SUITE 150 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRUS MICROSTENT |
| Generic Name | INTRAOCULAR PRESSURE LOWERING IMPLANT |
| Product Code | OGO |
| Date Received | 2020-03-20 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVANTIS, INC. |
| Manufacturer Address | 201 TECHNOLOGY IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |