| Report Number | 3003981983-2019-00002 |
| MDR Report Key | 8713900 |
| Date Received | 2019-06-19 |
| Date of Report | 2019-07-19 |
| Date of Event | 2019-05-18 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2014-11-08 |
| Date Added to Maude | 2019-06-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MELISSA TORPEY |
| Manufacturer Street | 5870 STONERIDGE DRIVE SUITE 1 |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 5857569874 |
| Manufacturer G1 | COOPERVISION MANUFACTURING LTD. |
| Manufacturer Street | CHANDLER FORD, ERITH HOUSE WARRIOR CLOSE |
| Manufacturer City | EASTLEIGH, HAMPSHIRE, SO534TE |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SO53 4TE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |