MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-15 for ARGUS II RETINAL PROSTHESIS 011015-001-K 011015 manufactured by Second Sight Medical Products, Inc..
| Report Number | 3004081696-2019-00007 |
| MDR Report Key | 9332221 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-11-15 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-10-16 |
| Date Mfgr Received | 2019-10-16 |
| Device Manufacturer Date | 2018-01-22 |
| Date Added to Maude | 2019-11-15 |
| 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 | PUNITA CHRISTOPHER |
| Manufacturer Street | 12744 SAN FERNANDO ROAD BUILDING 3 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8188334119 |
| Manufacturer G1 | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Street | 12744 SAN FERNANDO RD. SUITE 400 |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGUS II RETINAL PROSTHESIS |
| Generic Name | RETINAL PROSTHESIS |
| Product Code | NBF |
| Date Received | 2019-11-15 |
| Model Number | 011015-001-K |
| Catalog Number | 011015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECOND SIGHT MEDICAL PRODUCTS, INC. |
| Manufacturer Address | BUILDING 3 12744 SAN FERNANDO RD SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-15 |