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 2020-03-26 for FLIXENE GRAFT manufactured by Atrium Medical Corporation.
[186753368]
We are unable to fully investigate this report as no product number, lot number or sample was provided. It is not known what relationship the flixene has to the reported adverse events. The article found the use of the early cannulation graft flixene to be safe with a low complication rate and favourable patency rates. Based on the information available atrium has determined that the events described are not related to a product failure. Device evaluated by manufacturer? Not available for return.
Patient Sequence No: 1, Text Type: N, H10
[186753369]
Received an article titled single-centre experience of an early cannulation graft for haemodialysis access. Purpose: this article reports on the outcomes from the largest series to date using the early cannulation graft flixene in a single centre. Method: between may 2012 and march 2018, 141 flixene grafts were placed for dialysis access. The outcomes of the arteriovenous grafts were reviewed retrospectively from electronically held records and imaging. Per the article adverse events included graft infection, occlusion (steal syndrome) hematoma, seroma and thrombosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00458 |
| MDR Report Key | 9886940 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-26 |
| 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. LYNDA MCLAUGHLIN |
| 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 | 2020-03-26 |
| 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. Required No Informationntervention | 2020-03-26 |