MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Uterine Perforation (2121); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

A consumer reported having essure (fallopian tube occlusion insert) inserted for permanent birth control.She stated she was in a lot of pain.She came home and the pain continued.She also reported bleeding a lot.The pain got worse over the next five years.She is allergic to nickel.In (b)(6), her pain was so bad that she could not stand up.She suffered chronic pelvic pain with a possible misplaced essure.She had a hysterectomy (the only option her physician gave her).She was told that the essure device had perforated her uterus and was loose in her abdomen.

Manufacturer Narrative

Following internal review, it was noted that this report is a duplicate of case (b)(4) and will be deleted from bayer database.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 3587668
• MDR Text Key: 17991477
• Report Number: 2951250-2014-00003
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention