MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-21 for VENOVO VENOUS STENT SYSTEM VENEM12100 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
| Report Number | 9681442-2019-00079 |
| MDR Report Key | 8725300 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-21 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-10-01 |
| Device Manufacturer Date | 2019-03-25 |
| Date Added to Maude | 2019-06-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENOVO VENOUS STENT SYSTEM |
| Generic Name | VENOUS STENT |
| Product Code | QAN |
| Date Received | 2019-06-21 |
| Returned To Mfg | 2019-06-18 |
| Catalog Number | VENEM12100 |
| Lot Number | ANDP3953 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-21 |