MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-09 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48026 EVO-22-27-9-D manufactured by Cook Ireland Ltd.
| Report Number | 3001845648-2019-00459 |
| MDR Report Key | 8974189 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-09-09 |
| Date of Report | 2019-09-09 |
| Date of Event | 2019-08-13 |
| Date Facility Aware | 2019-08-13 |
| Date Mfgr Received | 2019-08-14 |
| Device Manufacturer Date | 2018-02-19 |
| Date Added to Maude | 2019-09-09 |
| 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. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer Phone | 061334440 |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MUM STENT, METALIC EXPANDABLE, DUODENAL |
| Product Code | MUM |
| Date Received | 2019-09-09 |
| Returned To Mfg | 2019-09-24 |
| Model Number | G48026 |
| Catalog Number | EVO-22-27-9-D |
| Lot Number | C1455667 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 540 DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-09 |