MAUDE Adverse Event Report: ESSURE COILS

Device Problems Component Falling (1105); Migration or Expulsion of Device (1395)

Patient Problems Heavier Menses (2666); Pregnancy (3193)

Event Date 02/03/2014

Event Type  Injury  

Event Description

I had a permanent birth control procedure called essure done on (b)(6) 2014 by doctor (b)(6).I had a depo provera shot as a birth control method until i have my confirmation test.On (b)(6) 2014 i had the hsg or confirmation test done to check if the procedure was effective.The test demonstrated bilateral fallopian occlusion, but it also showed that the left essure coil was somewhat peripherally placed within the left fallopian tube; nevertheless, it demonstrated fallopian occlusion.On (b)(6) 2014 i visited dr.(b)(6) because after the 3 months passed fo the essure and depo provera; i had heavy bleeding during my menstrual cycle which lasted for 3 consecutive months.Doctor (b)(6) prescribed progesterone 100 mg.On (b)(6) 2014 my left essure coil came out during my mentrual cycle, i had stomach cramps; while i was wiping myself clean and i went to see dr.(b)(6) and even brought the coil to her clinic to show her.She did an ultrasound to make sure the coil did not damage any organs.Dr.(b)(6) changed my progesterone pills to 220 mg to control my mentrual cycle.On (b)(6) 2014 i visited dr.(b)(6) because i had missed my menstrual cycle in (b)(6) 2014.She did a pregnancy test which came up positive.

• Brand Name: ESSURE COILS
• Type of Device: ESSURE COILS
• MDR Report Key: 4253542
• MDR Text Key: 4992802
• Report Number: MW5039051
• 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: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 68