MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Miscarriage (1962); Pain (1994); Pregnancy (3193)

Event Date 05/31/2012

Event Type  Death  

Event Description

(b)(4). I was implanted with the essure device in my gynecologists office. Not only did i have immense pain, i've had nothing but adverse effects since then, but my doctor refused to see me, and my medical records from my implanting doctor as well as other doctors i went to seeking help are falsified. Yes, i do have proof and documentation of my allegations. My unborn child that i conceived after a confirmation hsg test that claimed i was 100% occluded, was miscarried early in my pregnancy, which is why i used the check mark on the box that says death. My unborn child died as a result of this device.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4899748
• MDR Text Key: 6830220
• Report Number: MW5043734
• 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: 05/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 07/08/2015 Patient Sequence Number: 1