COUPLER 5111-00150-060

MAUDE Adverse Event Report

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 2019-09-17 for COUPLER 5111-00150-060 manufactured by Baxter Healthcare - Saint Paul - Mca.

MAUDE Entry Details

Report Number1416980-2019-05087
MDR Report Key9077591
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-09-17
Date of Report2019-10-23
Date of Event2019-07-24
Date Mfgr Received2019-10-11
Date Added to Maude2019-09-17
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
Manufacturer CitySAINT PAUL MN 55114
Manufacturer CountryUS
Manufacturer Postal Code55114
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOUPLER
Generic NameDEVICE, ANASTOMOTIC, MICROVASCULAR
Product CodeMVR
Date Received2019-09-17
Returned To Mfg2019-09-10
Model NumberNA
Catalog Number5111-00150-060
Lot NumberSP16D29-1147061
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - SAINT PAUL - MCA
Manufacturer AddressSAINT PAUL MN


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.