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 2019-09-17 for COUPLER 5111-00150-060 manufactured by Baxter Healthcare - Saint Paul - Mca.
Report Number | 1416980-2019-05087 |
MDR Report Key | 9077591 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-09-17 |
Date of Report | 2019-10-23 |
Date of Event | 2019-07-24 |
Date Mfgr Received | 2019-10-11 |
Date Added to Maude | 2019-09-17 |
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 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 | 2019-09-17 |
Returned To Mfg | 2019-09-10 |
Model Number | NA |
Catalog Number | 5111-00150-060 |
Lot Number | SP16D29-1147061 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BAXTER HEALTHCARE - SAINT PAUL - MCA |
Manufacturer Address | SAINT PAUL MN |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-09-17 |