MAUDE Adverse Event Report: BAYER ESSURE COILS

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 03/06/2012

Event Type  Injury  

Event Description

Received the essure coils (permanent birth control) in (b)(6) 2012.Got pregnant in (b)(6) 2013.Gave birth to a health girl (b)(6) 2013.During her birth a tubal ligation was performed and an attempt to locate and remove essure coils was performed.Coils could not be located and i still don't know where they are inside my body.

• Brand Name: ESSURE COILS
• Type of Device: ESSURE COILS
• Manufacturer (Section D): BAYER
• MDR Report Key: 5383885
• MDR Text Key: 36624229
• Report Number: MW5059501
• 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: 01/16/2016

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: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 95