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 2019-11-17 for MERIT COAXIAL MINI ACCESS KIT MAK401-E/C manufactured by Merit Medical Systems.
| Report Number | 3011642792-2019-00023 |
| MDR Report Key | 9333517 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-17 |
| Date of Report | 2019-10-22 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2019-10-22 |
| Device Manufacturer Date | 2019-03-22 |
| Date Added to Maude | 2019-11-17 |
| 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. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| 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 | MERIT COAXIAL MINI ACCESS KIT |
| Generic Name | MINI ACCESS KIT |
| Product Code | DRE |
| Date Received | 2019-11-17 |
| Catalog Number | MAK401-E/C |
| Lot Number | I1523621 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-11-17 |