MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Abdominal Pain (1685)

Event Date 10/14/2015

Event Type  Injury  

Event Description

(b)(4).Everything was covered by my insurance.When the essure was placed it was the most painful thing that i have ever experienced.At my one-month ultrasound i still had pain on my left side, but the coils were in the correct places.For four more months i experienced an aching pain on my left side.Yesterday, i had my confirmation test my right coil is missing.I still experience pain on my left side.The medical assistant who helped with my confirmation test said that she sees missing coils often.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5159592
• MDR Text Key: 28615452
• Report Number: MW5057138
• 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
• Reporter Occupation: Patient
• Report Date: 10/15/2015

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ADVIR 100/50ALLERGY SHOTS
• Patient Outcome(s): Required Intervention
• Patient Age: 37.000 YR