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 2019-08-16 for COUPLER 511100200060 manufactured by Synovis Surgical Innovations.
Report Number | 1416980-2019-04470 |
MDR Report Key | 8901239 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-08-16 |
Date of Report | 2019-09-17 |
Date of Event | 2019-07-19 |
Date Mfgr Received | 2019-09-04 |
Date Added to Maude | 2019-08-16 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 55114 |
Manufacturer Country | US |
Manufacturer Postal Code | 55114 |
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 | 2019-08-16 |
Model Number | NA |
Catalog Number | 511100200060 |
Lot Number | SP19F06-1377918 |
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 | 2019-08-16 |