MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-07-03 for COUPLER 511100250010 manufactured by Synovis Surgical Innovations.
[150016788]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[150016789]
It was reported that a patient underwent a radial forearm free-flap for head and neck reconstruction surgery in which a 2. 5mm coupler device was used. It was reported after deployment, the anastomosis? Bled/ leaked? Which resulted in removal of the coupler device. A new coupler? Of the same size? Was used and no additional issues were reported as a result of the explant and reapplication of a new coupler. It was reported the patient was? Doing great?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1416980-2019-03605 |
MDR Report Key | 8760552 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2019-07-03 |
Date of Report | 2019-10-29 |
Date of Event | 2019-05-21 |
Date Mfgr Received | 2019-10-24 |
Date Added to Maude | 2019-07-03 |
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 | 25212 W. ILLINOIS ROUTE 120 |
Manufacturer City | ROUND LAKE IL 60073 |
Manufacturer Country | US |
Manufacturer Postal | 60073 |
Manufacturer Phone | 2242702068 |
Manufacturer G1 | SYNOVIS SURGICAL INNOVATIONS |
Manufacturer Street | 2575 UNIVERSITY AVE. W |
Manufacturer City | SAINT PAUL MN 55144 |
Manufacturer Country | US |
Manufacturer Postal Code | 55144 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | COUPLER |
Generic Name | DEVICE, ANASTOMOTIC, MICROVASCULAR |
Product Code | MVR |
Date Received | 2019-07-03 |
Model Number | NA |
Catalog Number | 511100250010 |
Lot Number | SP19D17-1367451 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
Manufacturer Address | SAINT PAUL MN |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2019-07-03 |