ESOPHYX Z R2005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-13 for ESOPHYX Z R2005 manufactured by Endogastric Solutions, Inc..

MAUDE Entry Details

Report Number3005473391-2019-00123
MDR Report Key8890520
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-13
Date of Report2019-08-13
Date of Event2019-07-11
Date Mfgr Received2019-07-12
Device Manufacturer Date2017-07-18
Date Added to Maude2019-08-13
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 ContactMR. VISHNU VENKATESAN
Manufacturer Street18109 NE 76TH ST SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4253079248
Manufacturer G1ENDOGASTRIC SOLUTIONS, INC.
Manufacturer Street18109 NE 76TH ST SUITE 100
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal Code98052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameESOPHYX Z
Generic NameODE
Product CodeODE
Date Received2019-08-13
Model NumberR2005
Catalog NumberR2005
Lot Number402495
Device Expiration Date2019-07-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerENDOGASTRIC SOLUTIONS, INC.
Manufacturer Address18109 NE 76TH ST. SUITE 100 REDMOND WA 98052 US 98052


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-08-13

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