MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-25 for NUCLEUS 230 PVN229 manufactured by Numed Canada, Inc..
| Report Number | 9618000-2019-00008 |
| MDR Report Key | 9119558 |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2018-08-10 |
| Date Mfgr Received | 2019-09-13 |
| Device Manufacturer Date | 2018-01-24 |
| Date Added to Maude | 2019-09-25 |
| 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 | MS. NICHELLE LAFLESH |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal | 12965 |
| Manufacturer Phone | 3153284491 |
| Manufacturer G1 | NUMED CANADA, INC. |
| Manufacturer Street | 45 SECOND STREET WEST |
| Manufacturer City | CORNWALL, K6J 1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K6J 1G3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUCLEUS |
| Generic Name | BALLOON AORTIC VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2019-09-25 |
| Model Number | 230 |
| Catalog Number | PVN229 |
| Lot Number | Y-6832 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED CANADA, INC. |
| Manufacturer Address | 45 SECOND STREET WEST CORNWALL, K6J 1G3 CA K6J 1G3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-25 |