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 2019-07-09 for COUPLER 511100200010 manufactured by Synovis Surgical Innovations.
[150402276]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[150402277]
It was reported that a patient underwent an unspecified procedure in which a 2. 0mm coupler device was used. It was reported that? Once the vein was everted on the pins, the ring comes out of the black holder?. The process step was not reported. Another coupler device was used to complete the procedure. At the time of this report, the patient was? Doing well?. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-03671 |
| MDR Report Key | 8771430 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-09 |
| Date of Report | 2019-08-12 |
| Date Mfgr Received | 2019-07-29 |
| Date Added to Maude | 2019-07-09 |
| 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 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 | 2019-07-09 |
| Model Number | NA |
| Catalog Number | 511100200010 |
| Lot Number | SP18K13-1336534 |
| 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 | 2019-07-09 |