OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-09-30 for OPTIFLUX F18NRE DIALYZER FINISHED ASSY 0500308E manufactured by Ogden Manufacturing Plant.

MAUDE Entry Details

Report Number1713747-2019-00307
MDR Report Key9135845
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-09-30
Date of Report2019-11-19
Date of Event2019-09-07
Date Mfgr Received2019-11-12
Device Manufacturer Date2018-07-30
Date Added to Maude2019-09-30
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 ContactMATTHEW AMARAL
Manufacturer Street920 WINTER ST.
Manufacturer CityWALTHAM MA 02451
Manufacturer CountryUS
Manufacturer Postal02451
Manufacturer Phone7816999758
Manufacturer G1OGDEN MANUFACTURING PLANT
Manufacturer StreetDIRECTOR, SITE QUALITY 475 WEST 13TH STREET
Manufacturer CityOGDEN UT 84404
Manufacturer CountryUS
Manufacturer Postal Code84404
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIFLUX F18NRE DIALYZER FINISHED ASSY
Generic NameDIALYZER, CAPILLARY, HOLLOW FIBER
Product CodeFJI
Date Received2019-09-30
Catalog Number0500308E
Lot Number18JU01019
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOGDEN MANUFACTURING PLANT
Manufacturer Address475 WEST 13TH STREET OGDEN UT 84404 US 84404


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-30

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