MC3 7071

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-29 for MC3 7071 manufactured by Mc3 Inc..

MAUDE Entry Details

Report Number3011468686-2019-00004
MDR Report Key9643843
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2020-01-29
Date of Report2020-01-28
Date of Event2019-12-26
Date Mfgr Received2019-12-31
Device Manufacturer Date2018-02-01
Date Added to Maude2020-01-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMS. MARTHA RUMFORD
Manufacturer Street2555 BISHOP CIRCLE WEST
Manufacturer CityDEXTER MI 48130
Manufacturer CountryUS
Manufacturer Postal48130
Manufacturer Phone7349959089
Manufacturer G1MC3 INC.
Manufacturer Street2555 BISHOP CIRCLE WEST
Manufacturer CityDEXTER MI 48130
Manufacturer CountryUS
Manufacturer Postal Code48130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMC3
Generic NameCARDIOVASCULAR CANNULA
Product CodeDWF
Date Received2020-01-29
Model Number7071
Catalog Number7071
Lot Number1802100
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMC3 INC.
Manufacturer Address2555 BISHOP CIRCLE WEST DEXTER MI 48130 US 48130


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-29

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