MAUDE Adverse Event Report: BAYER ESSURE

Device Problems Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 06/18/2015

Event Type  Injury  

Event Description

(b)(4).I am filing on behalf of a (b)(6) old caucasian female (b)(6) nonsmoker who underwent the essure sterilization procedure in (b)(6) 2013.The device on the left migrated out of the fallopian tube--location unknown.

• Brand Name: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 4949924
• MDR Text Key: 16884117
• Report Number: MW5044893
• 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: Physician
• Type of Report: Initial
• Report Date: 06/26/2015

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35.000 YR