MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-21 for MYDAY (STENFILCON A) manufactured by Coopervision Manufacturing, Ltd..
| Report Number | 3003981983-2019-00003 |
| MDR Report Key | 9356417 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date Mfgr Received | 2019-10-23 |
| Device Manufacturer Date | 2018-11-30 |
| Date Added to Maude | 2019-11-21 |
| 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 | 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 | CHANDLERS 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 | 3 |
| Brand Name | MYDAY (STENFILCON A) |
| Generic Name | MYDAY (STENFILCON A) |
| Product Code | MVN |
| Date Received | 2019-11-21 |
| Lot Number | 5005811195 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERVISION MANUFACTURING, LTD. |
| Manufacturer Address | CHANDLERS FORD, ERITH HOUSE WARRIOR CLOSE EASTLEIGH, HAMPSHIRE SO534TE UK SO53 4TE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-21 |