MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Misfire (2532)

Patient Problems Pain (1994); Anxiety (2328); Depression (2361); Abdominal Distention (2601); Foreign Body In Patient (2687)

Event Date 02/01/2010

Event Type  Injury  

Event Description

Essure in (b)(6) 2010, back pain, severe abdominal bloating, anxiety and depression.Thought it was all due to being postpartum in (b)(6) 2009 and age (b)(6), but it has worsened, 7 years later.Had misfire during procedure and lost one of the coils the doctor said.They said they could see it in the x-ray the next day.Had recent transvaginal ultrasound and they can't see the right ovary.Bloating is so severe, people think i'm pregnant.I'm a rn and (b)(6) and there's no other reason found.I want it removed.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 6380966
• MDR Text Key: 69252830
• Report Number: MW5068287
• 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: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MOTRIN AS NEEDED.; OTC MEDS: VITAMIN D DAILY; RX MEDS: EFFEXOR; SYNTHROID; TYLENOL; VITAMIN B12.
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 68