GEM MICROVASCULAR ANASTOMOTIC COUPLER GEM2753/1 511100250010

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number8873282
MDR Report Key8873282
Date Received2019-08-08
Date of Report2019-08-01
Date of Event2019-05-21
Report Date2019-08-01
Date Reported to FDA2019-08-01
Date Reported to Mfgr2019-08-08
Date Added to Maude2019-08-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGEM MICROVASCULAR ANASTOMOTIC COUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2019-08-08
Model NumberGEM2753/1
Catalog Number511100250010
Lot NumberSP19D19-1368004
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSYNOVIS MICRO COMPANIES ALLIANCE, INC
Manufacturer Address439 INDUSTRIAL LN BIRMINGHAM AL 35211 US 35211


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-08

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