LIBERTY CYCLER SET, DUAL PATIENT CONNECT 050-87212

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 CYCLER SET, DUAL PATIENT CONNECT 050-87212 manufactured by Erika De Reynosa, S.a. De C.v..

MAUDE Entry Details

Report Number8030665-2019-01820
MDR Report Key9392036
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-12-02
Date of Event2019-11-06
Date Mfgr Received2019-12-02
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 G1ERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer StreetDIRECTOR, QUALITY SYSTEMS 1100 E, MILITARY HWY, SUITE C
Manufacturer CityPHARR TX 78577
Manufacturer CountryUS
Manufacturer Postal Code78577
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIBERTY CYCLER SET, DUAL PATIENT CONNECT
Generic NameSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Product CodeFKX
Date Received2019-11-29
Catalog Number050-87212
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeMO
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerERIKA DE REYNOSA, S.A. DE C.V.
Manufacturer AddressMIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780


Patients

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

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