MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-21 for BIOFINITY SPHERE (COMFILCON A) manufactured by Coopervision Manufacturing, Ltd..
| Report Number | 9614392-2019-00032 |
| MDR Report Key | 9354766 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-21 |
| Date of Report | 2019-11-21 |
| Date of Event | 2019-10-12 |
| Date Mfgr Received | 2019-10-22 |
| 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 |
| 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 | SOUTH POINT HAMBLE UNIT 2 |
| Manufacturer City | SOUTHAMPTOM, HAMPSHIRE SO314RF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SO31 4RF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOFINITY SPHERE (COMFILCON A) |
| Generic Name | BIOFINITY SPHERE (COMFILCON A) |
| Product Code | LPM |
| Date Received | 2019-11-21 |
| Lot Number | 11319050089014 |
| 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 | SOUTH POINT HAMBLE UNIT 2 SOUTHAMPTOM, HAMPSHIRE SO314RF UK SO31 4RF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2019-11-21 |