CER 1 OPTIMA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for CER 1 OPTIMA manufactured by Medivators Inc..

MAUDE Entry Details

Report Number2150060-2020-00009
MDR Report Key9836058
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2006-03-03
Date Added to Maude2020-03-16
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 ContactLAUREN JOHNSON
Manufacturer Street9800 59TH AVE N
Manufacturer CityPLYMOUTH, MN
Manufacturer CountryUS
Manufacturer G1MEDIVATORS INC.
Manufacturer Street14605 28TH AVE N
Manufacturer CityPLYMOUTH, MN
Manufacturer CountryUS
Single Use3
Remedial ActionNO
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCER 1 OPTIMA
Generic NameAUTOMATED ENDOSCOPE REPROCESSOR
Product CodeNVE
Date Received2020-03-16
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDIVATORS INC.
Manufacturer Address14605 28TH AVE N PLYMOUTH, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-16

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