MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-08 for GEM MICROVASCULAR ANASTOMOTIC COUPLER GEM2753/1 511100250010 manufactured by Synovis Micro Companies Alliance, Inc.
| Report Number | 8873282 |
| MDR Report Key | 8873282 |
| Date Received | 2019-08-08 |
| Date of Report | 2019-08-01 |
| Date of Event | 2019-05-21 |
| Report Date | 2019-08-01 |
| Date Reported to FDA | 2019-08-01 |
| Date Reported to Mfgr | 2019-08-08 |
| Date Added to Maude | 2019-08-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM MICROVASCULAR ANASTOMOTIC COUPLER |
| Generic Name | DEVICE, ANASTOMOTIC, MICROVASCULAR |
| Product Code | MVR |
| Date Received | 2019-08-08 |
| Model Number | GEM2753/1 |
| Catalog Number | 511100250010 |
| Lot Number | SP19D19-1368004 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNOVIS MICRO COMPANIES ALLIANCE, INC |
| Manufacturer Address | 439 INDUSTRIAL LN BIRMINGHAM AL 35211 US 35211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-08 |