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 2018-10-01 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED G48027 EVO-22-27-12-D manufactured by Cook Ireland Ltd.
[123677344]
The 510(k) number: k163468. (b)(4). Investigation is still pending, a follow up mdr will be submitted to include investigation conclusions.
Patient Sequence No: 1, Text Type: N, H10
[123677345]
This file is being reported based on the fda mdr malfunction precedence "stent fracture" the exact lot number is not known he will inform of this later. The product was used today and the stent broke. "as per complaint form": during a controlling, the new stent after 4 weeks, the physician find a disintegrated stent, in the original position. At least on 4 positons was the stent broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2018-00458 |
| MDR Report Key | 7922333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-01 |
| Date of Report | 2019-01-16 |
| Date of Event | 2018-07-31 |
| Date Facility Aware | 2018-10-01 |
| Date Mfgr Received | 2018-09-03 |
| Device Manufacturer Date | 2018-06-14 |
| Date Added to Maude | 2018-10-01 |
| 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 | 2018-10-01 |
| Model Number | G48027 |
| Catalog Number | EVO-22-27-12-D |
| Lot Number | C1510524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 47 DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-01 |