MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-06-05 for WARD PHOTONICS 60001 manufactured by Ward Photonics.
| Report Number | 3010053203-2019-00001 |
| MDR Report Key | 8670519 |
| Report Source | USER FACILITY |
| Date Received | 2019-06-05 |
| Date of Report | 2019-06-05 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-06 |
| Device Manufacturer Date | 2018-04-06 |
| Date Added to Maude | 2019-06-05 |
| 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. JEFF BROWN |
| Manufacturer Street | 1980 N ATLANTIC AVE SUITE 1008 |
| Manufacturer City | COCOA BEACH FL 32931 |
| Manufacturer Country | US |
| Manufacturer Postal | 32931 |
| Manufacturer Phone | 8016339660 |
| Manufacturer G1 | WARD PHOTONICS |
| Manufacturer Street | 1980 N ATLANTIC AVE SUITE 1008 |
| Manufacturer City | COCOA BEACH FL 32931 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32931 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WARD PHOTONICS |
| Generic Name | ULTRASLIM |
| Product Code | OLI |
| Date Received | 2019-06-05 |
| Model Number | 60001 |
| Catalog Number | 60001 |
| Lot Number | 180406-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARD PHOTONICS |
| Manufacturer Address | 1980 N ATLANTIC AVE. SUITE 1008 COCOA BEACH FL 32931 US 32931 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-06-05 |