MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for manufactured by .
| Report Number | COR19000441-000 |
| MDR Report Key | 9191670 |
| Date Received | 2019-10-11 |
| Date of Report | 2019-10-11 |
| Date Added to Maude | 2019-10-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | Yverre Bobay |
| Manufacturer Street | 530 Boston Post Road |
| Manufacturer City | Wayland MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal | 01778 |
| Manufacturer G1 | Candela Corporation |
| Manufacturer Street | 530 Boston Post Road |
| Manufacturer City | Wayland MA 01778 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01778 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | EWG |
| Date Received | 2019-10-11 |
| Device Availability | I |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-11 |