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 2019-04-05 for COUPLER 511100200060 manufactured by Baxter Healthcare - Saint Paul - Mca.
[141087608]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[141087609]
It was reported that a patient underwent surgery in which a 2. 0mm coupler device was used for a venous anastomosis on brachial ante free flap. It was reported the anastomosis was difficult to perform as the coupler? Was a little seized and the tightening has been made difficult?. The anastomosis was discontinued? A few seconds later, and it was then necessary to repair it with wire?. No further details were provided regarding medical interventions or patient outcome. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-01828 |
| MDR Report Key | 8488421 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-05 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-03-06 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-04-05 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | BAXTER HEALTHCARE - SAINT PAUL - MCA |
| 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 | 2019-04-05 |
| Model Number | NA |
| Catalog Number | 511100200060 |
| Lot Number | SP17B06-1212234 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2019-04-05 |