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 2020-03-02 for GRAFTS FLIXENE GRAFTS W/GDS 25138 manufactured by .
[181729520]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed. Not returned.
Patient Sequence No: 1, Text Type: N, H10
[181729521]
Report received stated patient was exhibiting severe redness and inflammation at graft implantation site. Flixene graft was explanted from patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2020-00360 |
| MDR Report Key | 9777728 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-02 |
| 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 | GRAFTS FLIXENE GRAFTS W/GDS |
| Generic Name | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
| Product Code | DSY |
| Date Received | 2020-03-02 |
| Model Number | 25138 |
| Catalog Number | 25138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |