MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Swelling (2091); Weight Changes (2607)

Event Date 11/01/2012

Event Type  Injury  

Event Description

(b)(4).Shooting stabbing pains in my left side.Never attributed it to essure.Still happening at least once a month if not more.I can't move when the pain hits.It's almost unbearable.I also get constant migraines, i'm always tired and never feel well rested, no energy, can't lose weight eventhough i work out 5-6 days a week.Always bloated.Have seen a doctor.Said i have a coil poking out if my left tube.Says i need a hysterectomy.I'm (b)(6) and just not mentally ready for that surgery.Essure is one of my biggest regrets.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4815197
• MDR Text Key: 5832046
• Report Number: MW5042931
• 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: 05/04/2015

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2015
• Patient Sequence Number: 1
• Treatment: NONE. I DON'T TAKE OTHER MEDICATIONS.
• Patient Outcome(s): Other
• Patient Age: 26.000 YR