OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-25 for OPTIFLUX 160NRE DIALYZER FINISHED ASSY. 0500316E manufactured by Ogden Manufacturing Plant.

MAUDE Entry Details

Report Number1713747-2020-00079
MDR Report Key9881774
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-25
Date of Report2020-03-26
Date of Event2020-03-13
Date Mfgr Received2020-03-13
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
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 160NRE DIALYZER FINISHED ASSY.
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-25
Model Number0500316E
Catalog Number0500316E
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOGDEN MANUFACTURING PLANT
Manufacturer AddressDIRECTOR, SITE QUALITY 475 WEST 13TH STREET OGDEN UT 84404 US 84404


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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