MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Component Falling (1105); Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Fatigue (1849); Flatus (1865); Thyroid Problems (2102); Cramp(s) (2193); Weight Changes (2607); Intermenstrual Bleeding (2665)

Event Date 09/01/2010

Event Type  Injury  

Event Description

(b)(4).First set fell out of fallopian tubes and were discovered in my uterus.Second set has migrated from my fallopian tubed and are now protruding into my uterus, so its likely they will fall out into my uterus again.Weight gain, abdominal bloating, thyroid disfunction, abnormal menstrual periods and severe cramping, fatigue.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4926258
• MDR Text Key: 21332751
• Report Number: MW5044471
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/24/2015

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49.000 YR