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 2019-08-06 for COUPLER GEM2752 511100200010 manufactured by Synovis Surgical Innovations.
| Report Number | 1416980-2019-04297 |
| MDR Report Key | 8865444 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-06 |
| Date of Report | 2019-09-12 |
| Date of Event | 2019-07-03 |
| Date Mfgr Received | 2019-08-28 |
| Date Added to Maude | 2019-08-06 |
| 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 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 | 2019-08-06 |
| Returned To Mfg | 2019-07-29 |
| Model Number | GEM2752 |
| Catalog Number | 511100200010 |
| Lot Number | SP19C19-1360962 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS SURGICAL INNOVATIONS |
| Manufacturer Address | SAINT PAUL MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-06 |