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 2019-07-03 for MAK-NV INTRODUCER SYSTEM MAK-NV-004/A manufactured by Merit Medical Systems.
| Report Number | 3011642792-2019-00012 |
| MDR Report Key | 8761006 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-03 |
| Date of Report | 2019-06-14 |
| Date of Event | 2019-06-13 |
| Date Mfgr Received | 2019-08-09 |
| Device Manufacturer Date | 2018-12-12 |
| Date Added to Maude | 2019-07-03 |
| 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 | MRS. KATIE SWENSON CQE,CBA,CQPA. |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012531600 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS |
| Manufacturer Street | 8830 SIEMPRE VIVA RD #100 |
| Manufacturer City | SAN DIEGO, CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAK-NV INTRODUCER SYSTEM |
| Generic Name | INTRODUCER SYSTEM |
| Product Code | GCB |
| Date Received | 2019-07-03 |
| Returned To Mfg | 2019-07-03 |
| Catalog Number | MAK-NV-004/A |
| Lot Number | I1477671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS |
| Manufacturer Address | 8830 SIEMPRE VIVA RD #100 SAN DIEGO, CA 92154 US 92154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-03 |