MAUDE Adverse Event Report: CONCEPTUS ESSURE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Ectopic Pregnancy (1819); Emotional Changes (1831); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Abdominal Distention (2601)

Event Date 12/30/2011

Event Type  Death  

Event Description

I had essure implanted because my dr said it was 100% effective with no known side effects. One year and a half i got pregnant and the pregnancy was ectopic. I went to the emergency room because my life was at risk. I now suffer heavy bleeding, migraines, bloating, nausea, mood swings, hair loss. I just found out that my right coil is in place and the left coil is not. Now at (b)(6) i'm facing hysterectomy. It's been a nightmare.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): CONCEPTUS
• MDR Report Key: 3471501
• MDR Text Key: 4085681
• Report Number: MW5032825
• 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: 10/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 11/15/2013 Patient Sequence Number: 1