MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for CP STENT 425 CP8Z28 manufactured by Numed, Inc..
[134460560]
This stent fracture was found during a literature search in january of 2019. Physician was contacted and no other information was available other than what was reported in the journal article. The device lot number was not given. The journal article is - j interven cardiol. 2018;31:244-250. Https://doi. Org/10. 1111/joic. 12460.
Patient Sequence No: 1, Text Type: N, H10
[134460561]
Bare cp stent fracture found referenced in a publication during an article review search.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2019-00005 |
| MDR Report Key | 8282439 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-01-28 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-28 |
| 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, INC. |
| Manufacturer Street | 2880 MAIN STREET |
| Manufacturer City | HOPKINTON NY 12965 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2019-01-28 |
| Model Number | 425 |
| Catalog Number | CP8Z28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NUMED, INC. |
| Manufacturer Address | 2880 MAIN STREET HOPKINTON NY 12965 US 12965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-28 |