MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Information (3190)

Event Date 02/03/2015

Event Type  Injury  

Event Description

Essure procedure done (b)(6).Test done on (b)(6) confirmed that the right coil is protruding out of fallopian tube and stuck in uterus.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4504087
• MDR Text Key: 5537468
• Report Number: MW5040647
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR
• Patient Weight: 64