MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for FLIXENE GRAFT manufactured by Atrium Medical Corporation.
[184433485]
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, the haemodialysis reliable outflow graft provides acceptable 12-month secondary patency rates and acceptable complication rates in a (b)(6) and (b)(6) multi-centre series of complex access patients. Product not available for return.
Patient Sequence No: 1, Text Type: N, H10
[184433486]
Received an article titled: hunter, j. E. (2019). The united kingdom and ireland experience of the haemodialysis reliable outflow graft for vascular access. The journal of vascular access, pp. 12-18. Purpose: to describe the uk and ireland experience of the haemodialysis reliable outflow graft in complex vascular access. Method: data from any patient undergoing haemodialysis reliable outflow graft were collected from eight (b)(6) and one (b)(6) centre. Per the article deaths occurred within the study period.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00437 |
| MDR Report Key | 9864834 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-23 |
| 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 Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLIXENE GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2020-03-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL CORPORATION |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-23 |