MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-02-08 for COUPLER 511100150010 manufactured by Baxter Healthcare - Saint Paul - Mca.
[135530880]
C jaloux, b. Betrand, a. Mayoly, m. Cegarra-escolano, c. Philandrianos. Microvascular anastomotic coupler: an unexpected adverse event, thieme e-journals-journal of reconstructive microsurgery/abstract, oculoplastic surgery, third edition, https://www. Thieme-connect. De/media/irm/efirst/lookinside/10-1055-s-0038-1677036-180263-1. Ipg. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[135530881]
It was reported that a patient underwent a revision surgery to remove a 1. 5mm coupler device which was used for an anastomosis between the anterolateral thigh (alt) pedicle veins and the dorsalis pedis veins. It was reported approximately nine months after the initial surgery, the patient complained of a small discomfort in the dorsum of the operated foot. An x-ray was performed which confirmed the device underneath the skin. The revision surgery removed the device and the artery was left anastomosed. It was reported there were no complications after the procedure. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-00666 |
| MDR Report Key | 8320634 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-02-08 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-28 |
| Date Added to Maude | 2019-02-08 |
| 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 | 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 | 2019-02-08 |
| Model Number | NA |
| Catalog Number | 511100150010 |
| Lot Number | NI |
| 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 | 2019-02-08 |