MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Flatus (1865); Menstrual Irregularities (1959); Burning Sensation (2146); Constipation (3274)

Event Date 06/01/2010

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 04-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("abdominal pain") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2010, 1 year after insertion of essure, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), flatulence ("a lot of flatulence"), dysmenorrhea ("pain worsened in relation to my menstrual cycle") and gastrointestinal motility disorder ("intestinal transit became totally disrupted with alternating diarrhea and constipation").In 2012, the patient experienced abdominal discomfort ("burning sensations in the lower abdomen").The patient was treated with surgery (salpingectomy on (b)(6) 2012 and endometrial resection in (b)(6) 2015) and surgery (colonoscopy).Essure was removed on (b)(6) 2012.At the time of the report, the abdominal pain, flatulence, dysmenorrhoea, gastrointestinal motility disorder and abdominal discomfort outcome was unknown.The reporter provided no causality assessment for abdominal discomfort, abdominal pain, dysmenorrhoea, flatulence and gastrointestinal motility disorder with essure.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; whippany, NJ 07981
• MDR Report Key: 6816256
• MDR Text Key: 83468862
• Report Number: 2951250-2017-03100
• 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,foreign,other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• 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): Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 72