MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-22 for VENUS SYR 1 X 4G-A2 66007367 manufactured by Kulzer Gmbh.
| Report Number | 1821514-2019-00010 |
| MDR Report Key | 8813138 |
| Date Received | 2019-07-22 |
| Date of Report | 2019-07-22 |
| Date of Event | 2018-02-06 |
| Date Facility Aware | 2019-07-02 |
| Report Date | 2019-07-22 |
| Date Reported to Mfgr | 2019-07-22 |
| Date Added to Maude | 2019-07-22 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS SYR 1 X 4G-A2 |
| Generic Name | DENTAL COMPOSITE, RESIN DEVICES |
| Product Code | EBF |
| Date Received | 2019-07-22 |
| Catalog Number | 66007367 |
| Lot Number | K010509 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER GMBH |
| Manufacturer Address | PHILIPP-REIS-STRABE 8/13 WEHRHEIM, D-61273 GM D-61273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-22 |