MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2020-03-30 for BIOMIMICS 3D VASCULAR STENT SYSTEM 131816-01 manufactured by Veryan Medical.
| Report Number | 3011632150-2020-00023 |
| MDR Report Key | 9896982 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-07-02 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-12-21 |
| Date Added to Maude | 2020-03-30 |
| 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 ALAN MCDONAGH |
| Manufacturer Street | UNIT 11 GALWAY TECHNOLOGY PARK PARKMORE |
| Manufacturer City | GALWAY, GALWAY H91 VE0H |
| Manufacturer Country | EI |
| Manufacturer Postal | H91 VE0H |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOMIMICS 3D VASCULAR STENT SYSTEM |
| Generic Name | BIOMIMICS 3D VASCULAR STENT SYSTEM |
| Product Code | NIP |
| Date Received | 2020-03-30 |
| Catalog Number | 131816-01 |
| Lot Number | 381850 |
| Device Expiration Date | 2018-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERYAN MEDICAL |
| Manufacturer Address | UNIT 11 GALWAY TECHNOLOGY PARK PARKMORE GALWAY, GALWAY H91 VE0H EI H91 VE0H |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-30 |