MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-20 for YC-1800 manufactured by Nidek Co. Ltd..
| Report Number | 0002936921-2019-00010 |
| MDR Report Key | 9351336 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-20 |
| Date of Report | 2019-11-20 |
| Date of Event | 2019-11-13 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 2017-05-08 |
| Date Added to Maude | 2019-11-20 |
| 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 | MR. TODD MILHOLLAND |
| Manufacturer Street | 2040 CORPORATE COURT |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 5103537702 |
| Manufacturer G1 | NIDEK CO. LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2019-11-20 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO. LTD. |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-20 |