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 |