LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for LIBERTY SELECT CYCLER ASSY(NON-VALUATED) 180343 RTLR180343 manufactured by Concord Manufacturing.

MAUDE Entry Details

Report Number2937457-2020-00569
MDR Report Key9908839
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-03-19
Date Mfgr Received2020-03-19
Device Manufacturer Date2014-11-26
Date Added to Maude2020-03-31
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 Received2020-03-31
Model Number180343
Catalog NumberRTLR180343
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeMO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCONCORD MANUFACTURING
Manufacturer AddressDIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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