MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Material Fragmentation (1261)

Patient Problems Headache (1880); Pain (1994); Tingling (2171); Device Embedded In Tissue or Plaque (3165)

Event Date 01/01/2016

Event Type  Injury  

Event Description

(b)(4).I had the coils removed and still experience the side effects.After going to a different doctor i found out there was still fragments left inside me.I started getting severe migraines and my legs started tingling all the time and my back started to be hurting very badly all the time now.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 5404619
• MDR Text Key: 37305032
• Report Number: MW5059892
• 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
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32.000 YR