PRISMAFLEX HF1000 107140

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for PRISMAFLEX HF1000 107140 manufactured by Baxter Healthcare Corporation.

MAUDE Entry Details

Report Number8010182-2020-00019
MDR Report Key9864919
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-26
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-23
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 Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1BAXTER HEALTHCARE - MEYZIEU
Manufacturer Street7, AV LIONEL TERRAY, B.P. 126
Manufacturer CityMEYZIEU CEDEX RHONE 69883
Manufacturer CountryFR
Manufacturer Postal Code69883
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRISMAFLEX HF1000
Generic NameDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Product CodeKDI
Date Received2020-03-23
Model NumberNA
Catalog Number107140
Lot Number19H2903
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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