MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Emotional Changes (1831); Pain (1994)

Event Date 01/29/2015

Event Type  Death  

Event Description

(b)(4).Suicide, death.Pain and problems from essure.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4660870
• MDR Text Key: 5681441
• Report Number: MW5041820
• 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: 06/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death