LIBERTY SELECT CYCLER ASSY(NON-VALUATED) RTLR180343

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 2019-11-29 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) RTLR180343 manufactured by Concord Manufacturing.

MAUDE Entry Details

Report Number2937457-2019-03493
MDR Report Key9392033
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-06
Date Mfgr Received2019-11-15
Device Manufacturer Date2016-09-30
Date Added to Maude2019-11-29
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 NameLIBERTY SELECT CYCLER ASSY(NON-VALUATED)
Generic NameSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Product CodeFKX
Date Received2019-11-29
Catalog NumberRTLR180343
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCONCORD MANUFACTURING
Manufacturer AddressDIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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