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 Number: 3005473391-2019-00123
• MDR Report Key: 8890520
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2019-08-13
• Date of Report: 2019-08-13
• Date of Event: 2019-07-11
• Date Mfgr Received: 2019-07-12
• Device Manufacturer Date: 2017-07-18
• Date Added to Maude: 2019-08-13
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. VISHNU VENKATESAN
• Manufacturer Street: 18109 NE 76TH ST SUITE 100
• Manufacturer City: REDMOND WA 98052
• Manufacturer Country: US
• Manufacturer Postal: 98052
• Manufacturer Phone: 4253079248
• Manufacturer G1: ENDOGASTRIC SOLUTIONS, INC.
• Manufacturer Street: 18109 NE 76TH ST SUITE 100
• Manufacturer City: REDMOND WA 98052
• Manufacturer Country: US
• Manufacturer Postal Code: 98052
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ESOPHYX Z
• Generic Name: ODE
• Product Code: ODE
• Date Received: 2019-08-13
• Model Number: R2005
• Catalog Number: R2005
• Lot Number: 402495
• Device Expiration Date: 2019-07-18
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENDOGASTRIC SOLUTIONS, INC.
• Manufacturer Address: 18109 NE 76TH ST. SUITE 100 REDMOND WA 98052 US 98052

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2019-08-13