MAUDE Adverse Event Report: BAYER ESSURE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Death (1802); Fever (1858); Perforation (2001)

Event Date 03/18/2013

Event Type  Death  

Event Description

I was implanted with the essure device (b)(6) of 2011.I became pregnant in 2012.On (b)(6) 2013, i had to deliver my son (b)(6), but he had already died in utero three to four days prior.On (b)(6) 2013, i went back in for surgery to have my fallopian tubes removed.Upon awakening i was informed the essure on one side had migrated and perforated my uterus with a possibility of later puncturing my bowel.Therefore, i needed a hysterectomy.On (b)(6), i went back under to have the hysterectomy; however, leaving my ovaries.Three days later i was back in the hospital with a fever of 103.Nothing came of the fever but now i am missing my son and a body part.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER
• MDR Report Key: 3895975
• MDR Text Key: 4423204
• Report Number: MW5036798
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Death; Life Threatening
• Patient Age: 33 YR
• Patient Weight: 88