MAUDE Adverse Event Report: CONCEPTUS ESSURE ESSURE COILS

Model Number ESS305-R1

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Headache (1880); Hemorrhage/Bleeding (1888); Malaise (2359); Depression (2361)

Event Date 02/25/2013

Event Type  No Answer Provided  

Event Description

I am a mother of 3. My last two pregnancies were 2007 and 2008. I desired no more children. My gyno suggested the iud mirena. It was unsuccessful, so they suggested essure. I had the coils inserted in 2010. First 6 months was fine. Normal period. Even light at times. But i started to feel like i had the flu everyday and i was bleeding through my clothes. Constant headaches. Depression increased. Was told i had a hormone imbalance. Had an ablation the summer of 2011. One day surgery at (b)(6) hospital. Periods were somewhat normal for about 8 months. Then the side effects mentioned previously progressed. My periods were unstable and heavy and put me in the bed. How can you be a mother, wife, employee when you feel like you are dying?.

• Brand Name: ESSURE
• Type of Device: ESSURE COILS
• Manufacturer (Section D): CONCEPTUS; mountainview CA
• MDR Report Key: 3101345
• MDR Text Key: 3162097
• Report Number: MW5030089
• 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: 05/03/2013
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: ESS305-R1
• Device Catalogue Number: ESS305-R1
• Device Lot Number: 12397881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 05/03/2013 Patient Sequence Number: 1