MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for PICOWAY 9914-00-9060 manufactured by .
| Report Number | 1218402-2020-00022 |
| MDR Report Key | 9891749 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | MRS. YVERRE BOBAY |
| Manufacturer Street | 530 BOSTON POST ROAD |
| Manufacturer City | WAYLAND, MA |
| Manufacturer Country | US |
| Manufacturer Phone | 3580304 |
| Manufacturer G1 | CANDELA CORPORATION |
| Manufacturer Street | 530 BOSTON POST ROAD |
| Manufacturer City | WAYLAND, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PICOWAY |
| Generic Name | PICOWAY |
| Product Code | GEX |
| Date Received | 2020-03-27 |
| Model Number | 9914-00-9060 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |