MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-02-10 for MENICON ASRB (ASMOFILCONA) manufactured by Menicon Co., Ltd..
| Report Number | 1000188353-2019-00001 |
| MDR Report Key | 9686166 |
| Report Source | FOREIGN |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2019-10-04 |
| Date Added to Maude | 2020-02-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. YUKIE HIDAKA |
| Manufacturer Street | 21-19 AOI, 3-CHOME NAKA-KU |
| Manufacturer City | NAGOYA, 460-0006 |
| Manufacturer Country | JA |
| Manufacturer Postal | 460-0006 |
| Manufacturer G1 | MENICON SEKI PLANT |
| Manufacturer Street | 3, SHINHASAMA, SEKI, GIFU |
| Manufacturer City | 501-3923 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 501-3923 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENICON ASRB (ASMOFILCONA) |
| Generic Name | SILICONE HYDROGEL SOFT CONTACT LENS |
| Product Code | LPL |
| Date Received | 2020-02-10 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENICON CO., LTD. |
| Manufacturer Address | 21-19 AOI, 3-CHOME NAKA-KU NAGOYA, 460-0006 JA 460-0006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2020-02-10 |