COUPLER 511100250010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-07-03 for COUPLER 511100250010 manufactured by Synovis Surgical Innovations.

MAUDE Entry Details

Report Number1416980-2019-03596
MDR Report Key8759314
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2019-07-03
Date of Report2019-08-14
Date of Event2019-05-02
Date Mfgr Received2019-08-09
Date Added to Maude2019-07-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1SYNOVIS SURGICAL INNOVATIONS
Manufacturer Street2575 UNIVERSITY AVE. W NI
Manufacturer CitySAINT PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal Code55144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE,ANASTOMOTIC,MICROVASCULAR
Product CodeMVR
Date Received2019-07-03
Returned To Mfg2019-08-07
Model NumberNA
Catalog Number511100250010
Lot NumberSP19A22-1348900
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSYNOVIS SURGICAL INNOVATIONS
Manufacturer AddressSAINT PAUL MN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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