MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-04 for UNKPULSERIDER manufactured by Pulsar Vascular.
| Report Number | 3008680601-2020-00005 |
| MDR Report Key | 9666926 |
| Report Source | LITERATURE |
| Date Received | 2020-02-04 |
| Date of Report | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-04 |
| 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. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | PULSAR VASCULAR |
| Manufacturer Street | 130 KNOWLES DR SUITE E |
| Manufacturer City | LOS GATOS CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKPULSERIDER |
| Generic Name | INTRACRANIAL NEUROVASCULAR STENT |
| Product Code | NJE |
| Date Received | 2020-02-04 |
| Catalog Number | UNKPULSERIDER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULSAR VASCULAR |
| Manufacturer Address | 130 KNOWLES DR SUITE E LOS GATOS CA 95032 US 95032 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-04 |