OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-24 for OPTIFLUX 180NRE DIALYZER FINISHED ASSY. 0500318E manufactured by Ogden Manufacturing Plant.

MAUDE Entry Details

Report Number1713747-2020-00077
MDR Report Key9874178
Report SourceUSER FACILITY
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-03-14
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-11-10
Date Added to Maude2020-03-24
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 180NRE DIALYZER FINISHED ASSY.
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-24
Model Number0500318E
Catalog Number0500318E
Lot Number19PU01004
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 2020-03-24

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