MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for PARAGON CRT100 manufactured by Paragon Vision Sciences,inc..
| Report Number | 2020433-2019-00014 |
| MDR Report Key | 9148211 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2018-12-08 |
| Date Added to Maude | 2019-10-02 |
| 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. VIMALA PUNSAMMY |
| Manufacturer Street | 947 E. IMPALA AVE. |
| Manufacturer City | MESA, |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PARAGON CRT100 |
| Generic Name | ORTHO-K LENS |
| Product Code | NUU |
| Date Received | 2019-10-02 |
| Returned To Mfg | 2019-09-09 |
| Model Number | PARAGON CRT100 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARAGON VISION SCIENCES,INC. |
| Manufacturer Address | 947 E. IMPALA AVE. MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-02 |