MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-10-30 for ENTERPRISE2 4MMX16MM ENCR401612 manufactured by Codman And Shurtleff, Inc.
| Report Number | 1226348-2019-01009 |
| MDR Report Key | 9256752 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-10-30 |
| Date of Report | 2019-10-12 |
| Date of Event | 2019-10-09 |
| Date Mfgr Received | 2019-11-04 |
| Device Manufacturer Date | 2019-07-15 |
| Date Added to Maude | 2019-10-30 |
| 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. GABRIEL ALFAGEME |
| Manufacturer Street | 31 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERPRISE2 4MMX16MM |
| Generic Name | INTRACRANIAL NEUROVASCULAR STENT |
| Product Code | NJE |
| Date Received | 2019-10-30 |
| Returned To Mfg | 2019-10-25 |
| Catalog Number | ENCR401612 |
| Lot Number | 11163863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-30 |