HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP) C270020 101356604

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-30 for HOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP) C270020 101356604 manufactured by Avanos Medical - Irvine.

MAUDE Entry Details

Report Number2026095-2020-00045
MDR Report Key9896811
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-06
Date Mfgr Received2020-03-04
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LISA CLARK
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA GA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485444
Manufacturer G1AVENT S. DE R.L. DE C.V.
Manufacturer StreetAVE NORUEGA EDIFICIO D-1B FRACCIONAMIENTO RUBIO
Manufacturer CityTIJUANA B.C. 22116
Manufacturer CountryMX
Manufacturer Postal Code22116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHOMEPUMP C-SERIES, 270 ML, 2 ML/HR (CONTAINS DEHP)
Generic NameELASTOMERIC LFR
Product CodeMEB
Date Received2020-03-30
Model NumberC270020
Catalog Number101356604
Lot Number0203068909
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerAVANOS MEDICAL - IRVINE
Manufacturer Address43 DISCOVERY SUITE 100 IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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