MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-11 for GRAFTS ADVANTA VXT W/GDS 22114 manufactured by Atrium Medical Corporation.
[183900040]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[183900041]
During arteriovenous graft surgery, graft was torn.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011175548-2020-00280 |
MDR Report Key | 9697040 |
Report Source | COMPANY REPRESENTATIVE,DISTRI |
Date Received | 2020-02-11 |
Date of Report | 2020-02-11 |
Date of Event | 2020-01-22 |
Date Mfgr Received | 2020-01-23 |
Device Manufacturer Date | 2019-09-23 |
Date Added to Maude | 2020-02-11 |
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 ADVANTA VXT W/GDS |
Generic Name | PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER |
Product Code | DYF |
Date Received | 2020-02-11 |
Model Number | 22114 |
Catalog Number | 22114 |
Lot Number | 450786 |
Operator | HEALTH PROFESSIONAL |
Device Availability | * |
Device Eval'ed by Mfgr | * |
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 | 2020-02-11 |