MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-03 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[107710212]
The covered cp stent was not returned to numed, so the malfunction could not be confirmed. One stent from the lot was pulled and tested for covering strength before the lot was released for distribution. The stent met all criteria for covering strength as per the specification.
Patient Sequence No: 1, Text Type: N, H10
[107710213]
As per the report from the physician and distributor - "the ptfe was detached from the cp when the physician took it. It happened before the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2018-00005 |
| MDR Report Key | 7483641 |
| Date Received | 2018-05-03 |
| Date of Report | 2018-05-03 |
| Date of Event | 2018-03-19 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2015-07-29 |
| Date Added to Maude | 2018-05-03 |
| 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 | 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 | COVERED CP STENT |
| Generic Name | AORTIC STENT |
| Product Code | PNF |
| Date Received | 2018-05-03 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0611 |
| 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 | 2018-05-03 |