MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; INSERT, TUBAL OCCLUSION

Model Number ESS305

Device Problem Misfire (2532)

Patient Problem No Information (3190)

Event Date 09/03/2013

Event Type  malfunction  

Event Description

When preparing for insertion, the essure misfired.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 3792080
• MDR Text Key: 21241804
• Report Number: 3792080
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/20/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: ESS305
• Device Lot Number: 50713475
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2014
• Patient Sequence Number: 1
• Patient Age: 30 YR