MAUDE Adverse Event Report: BAYER ESSURE BIRTH CONTROL

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Abdominal Pain (1685)

Event Date 11/11/2015

Event Type  Injury  

Event Description

I had the essure birth control implanted i 2012.Recently i started having abdominal pain, have been to er 3 times.Went back to see obgyn, he determined the left coil is now missing and the right coil has moved and is stabbing me.He has to do surgery to remove both my tubes and look throughout entire pelvis for missing coil.If he finds it, may have to do full hysterectomy.Do not know how they migrated.

• Brand Name: ESSURE BIRTH CONTROL
• Type of Device: ESSURE BIRTH CONTROL
• Manufacturer (Section D): BAYER
• MDR Report Key: 5235245
• MDR Text Key: 31579990
• Report Number: MW5057947
• 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: 11/12/2015

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?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PEPCID
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Weight: 56