MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-10 for HUBBLE manufactured by St. Shine Optical Co., Ltd..
| Report Number | 9617499-2020-00001 |
| MDR Report Key | 9810275 |
| Report Source | OTHER |
| Date Received | 2020-03-10 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEREMY LIN |
| Manufacturer Street | 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD., HSI CHIH DIST., |
| Manufacturer City | NEW TAIPEI CITY, 221 |
| Manufacturer Country | TW |
| Manufacturer Postal | 221 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUBBLE |
| Generic Name | SOFT CONTACT LENS |
| Product Code | LPL |
| Date Received | 2020-03-10 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. SHINE OPTICAL CO., LTD. |
| Manufacturer Address | 4,5 F/L NO. 276-2 SEC. 1 TATUNG RD., HSI CHIH DIST., NEW TAIPEI CITY, 221 TW 221 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |