MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-08-08 for VENUS VERSA SYSTEM COMMON MODEL VE102407 manufactured by Venus Concept Ltd..
| Report Number | 3008915316-2018-00001 |
| MDR Report Key | 8872760 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-08-08 |
| Date of Report | 2018-11-14 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-11-14 |
| Date Added to Maude | 2019-08-08 |
| 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. YONI IGER |
| Manufacturer Street | HAYOZMA STREET, BLD. 6 |
| Manufacturer City | YOKNE'AM ILLIT, 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal | 2069203 |
| Manufacturer G1 | VENUS CONCEPT LTD. |
| Manufacturer Street | HAYOZMA STREET, BLD. 6 |
| Manufacturer City | YOKNE'AM ILLIT, 2069203 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 2069203 |
| Single Use | 0 |
| Remedial Action | PM |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS VERSA SYSTEM |
| Generic Name | VENUS VERSA SYSTEM |
| Product Code | ONF |
| Date Received | 2019-08-08 |
| Model Number | COMMON MODEL |
| Catalog Number | VE102407 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENUS CONCEPT LTD. |
| Manufacturer Address | HAYOZMA STREET, BLD. 6 YOKNE'AM, 2069203 IS 2069203 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2019-08-08 |