MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Emotional Changes (1831); Pain (1994); Perforation (2001); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 10/14/2013

Event Type  Injury  

Event Description

(b)(4).The same day of the implant i knew something was wrong.I was in unbearable pain.I called the doctor the next day and she requested me to take over the counter pain medication.The didn't cease so i went to another doctor to get an x-ray and she found that my left tube had been punctured by the essure.The coil spring in my right had migrated somewhere.Immediately after the new doctor prescribed norco for my pain and scheduled me for surgery.Me being frightened i didn't want a total hysterectomy.So in turn i had one tube removed and the doctor said to be totally pain free i would have to have the totally hysterectomy.I am a still in pain,mood swings, sleepless night, very forgetful and a lot of confusion daily.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4906137
• MDR Text Key: 20148861
• Report Number: MW5043960
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/09/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 37.000 YR