ESTEEM 2001 902001-002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-01 for ESTEEM 2001 902001-002 manufactured by Envoy Medical Corporation.

MAUDE Entry Details

• Report Number: 3004007782-2019-00002
• MDR Report Key: 8570758
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-05-01
• Date of Report: 2019-05-01
• Date of Event: 2019-04-30
• Date Mfgr Received: 2019-04-29
• Device Manufacturer Date: 2011-11-16
• Date Added to Maude: 2019-05-01
• 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. MAKSIM TROFIMOVICH
• Manufacturer Street: 4875 WHITE BEAR PARKWAY
• Manufacturer City: WHITE BEAR LAKE MN 551108057
• Manufacturer Country: US
• Manufacturer Postal: 551108057
• Manufacturer Phone: 6513618029
• Manufacturer G1: ENVOY MEDICAL CORPORATION
• Manufacturer Street: 4875 WHITE BEAR PARKWAY
• Manufacturer City: WHITE BEAR LAKE MN 551108057
• Manufacturer Country: US
• Manufacturer Postal Code: 551108057
• Single Use: 3
• Remedial Action: RL
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ESTEEM
• Generic Name: ESTEEM II, PRODUCT CODE: OAF
• Product Code: OAF
• Date Received: 2019-05-01
• Returned To Mfg: 2019-04-29
• Model Number: 2001
• Catalog Number: 902001-002
• Lot Number: EMC0004477
• Device Expiration Date: 2012-11-16
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ENVOY MEDICAL CORPORATION
• Manufacturer Address: 4875 WHITE BEAR PARKWAY WHITE BEAR LAKE MN 55110 US 55110

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-05-01