2008T GEN 2 BIBAG WITHOUT CDX 190895

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-21 for 2008T GEN 2 BIBAG WITHOUT CDX 190895 manufactured by Concord Manufacturing.

MAUDE Entry Details

Report Number2937457-2019-03214
MDR Report Key9213086
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-21
Date of Report2019-11-05
Date of Event2019-10-04
Date Mfgr Received2019-11-04
Device Manufacturer Date2017-09-26
Date Added to Maude2019-10-21
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 G1CONCORD MANUFACTURING
Manufacturer StreetDIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE
Manufacturer CityCONCORD CA 94520
Manufacturer CountryUS
Manufacturer Postal Code94520
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2008T GEN 2 BIBAG WITHOUT CDX
Generic NameDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Product CodeKPO
Date Received2019-10-21
Catalog Number190895
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONCORD MANUFACTURING
Manufacturer Address4040 NELSON AVENUE CONCORD CA 94520 US 94520


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-21

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