MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Material Fragmentation (1261); Loose or Intermittent Connection (1371)

Patient Problems Fatigue (1849); Pain (1994); Anxiety (2328)

Event Date 01/14/2015

Event Type  Injury  

Event Description

(b)(4).Healthy woman before the insertion of the device with no medical problems.Once essure was placed i immediately had pain and it never went away.Severe pelvic pain, pain during and after sex, stabbing pains in my right side, blood levels all over the place, fatigue, anxiety, severe bloating, and i had a total hysterectomy including tubes (b)(6) 2015 and i am still in pain from the device and have fragments loose in me.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5396359
• MDR Text Key: 36998454
• Report Number: MW5059705
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 28.000 YR