MICROGARD II V-892381

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-06-06 for MICROGARD II V-892381 manufactured by Vyaire Medical.

MAUDE Entry Details

Report Number9615102-2019-00105
MDR Report Key8676573
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-06-06
Date of Report2019-05-17
Date of Event2019-05-17
Date Mfgr Received2019-05-17
Date Added to Maude2019-06-06
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 ContactSTANLEY TAN
Manufacturer Street22745 SAVI RANCH PKWY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149193324
Manufacturer G1VYAIRE MEDICAL GERMANY 234 GMBH
Manufacturer StreetLEIBNIZSTRASSE 7
Manufacturer CityHOCHBERG, 97204
Manufacturer CountryGM
Manufacturer Postal Code97204
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICROGARD II
Generic NameFILTER, BACTERIAL, BREATHING CIRCUIT
Product CodeCAH
Date Received2019-06-06
Model NumberV-892381
Catalog NumberV-892381
Lot Number153948-48
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL
Manufacturer Address22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-06

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