MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-27 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..
[78608464]
The device has not yet been returned to numed. It is being held by the fda at customs. A photograph of the covered cp stent was sent to numed along with the complaint. From the pictures it appears that the covering and the glue spots are still intact. Numed can't at this time confirm this complaint. If more information becomes available, a follow-up report will be sent in. Being held at customs by the fda.
Patient Sequence No: 1, Text Type: N, H10
[78608465]
As per the report from the (b)(6) distributor - "professor brown opened the stent and it looked like the outer coating had been ripped. Professor opted to rather open and use another cvrd 45 stent with no problems. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1318694-2017-00016 |
| MDR Report Key | 6669168 |
| Date Received | 2017-06-27 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-05-26 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2016-08-02 |
| Date Added to Maude | 2017-06-27 |
| 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 | 2017-06-27 |
| Returned To Mfg | 2017-06-29 |
| Model Number | 427 |
| Catalog Number | CVRDCP8Z45 |
| Lot Number | CCP-0711 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-06-27 |