GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL 0FD2251-3B

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 2019-07-19 for GRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL 0FD2251-3B manufactured by Oregon Manufacturing Plant.

MAUDE Entry Details

Report Number3005162618-2019-00030
MDR Report Key8808078
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-19
Date of Report2019-08-20
Date of Event2019-06-19
Date Mfgr Received2019-08-12
Device Manufacturer Date2019-04-29
Date Added to Maude2019-07-19
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 G1OREGON MANUFACTURING PLANT
Manufacturer StreetDIRECTOR, QUALITY SYSTEMS 750 N LALLENDORF ROAD
Manufacturer CityOREGON OH 43616
Manufacturer CountryUS
Manufacturer Postal Code43616
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRANUFLO 2251 2K 2.5CA 1MG 16.5 GAL
Generic NameDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Product CodeKPO
Date Received2019-07-19
Catalog Number0FD2251-3B
Lot Number19DXGF022
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOREGON MANUFACTURING PLANT
Manufacturer Address750 N LALLENDORF ROAD OREGON OH 43616 US 43616


Patients

Patient NumberTreatmentOutcomeDate
120081. Required No Informationntervention 2019-07-19

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