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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Tinnitus (2103); Visual Impairment (2138); Dizziness (2194); Arthralgia (2355); Abdominal Distention (2601); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for essure insertion: general anesthesia.In 2013, the patient had essure inserted.On the same day, the patient experienced visual impairment ("when i woke up i was incapable of reading anything whatsoever, vision declining, since then wearing glasses").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("major chronic fatigue"), dizziness ("random dizzy spells"), headache ("headaches"), arthralgia ("hip pain"), inflammation ("blood test results shows signs of inflammation though no one tries to find out why"), abdominal pain upper ("random stomach pain"), weight increased ("major weight gain"), abdominal distension ("swollen abdomen"), menopause ("menopause at (b)(6)") and tinnitus ("tinnitus").The patient was to be operated soon.Essure treatment was not changed.At the time of the report, the pelvic pain, visual impairment, fatigue, dizziness, headache, arthralgia, inflammation, abdominal pain upper, weight increased, abdominal distension, menopause and tinnitus outcome was unknown.The reporter considered abdominal distension, abdominal pain upper, arthralgia, dizziness, fatigue, headache, inflammation, menopause, pelvic pain, tinnitus, visual impairment and weight increased to be related to essure.The reporter commented: yes, these things happen, but obviously i make the connection with essure.Diagnostic results (normal ranges are provided in parenthesis if available): blood test - on an unknown date: signs of inflammation (abnormal nos).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 12-jul-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 3.083 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Further company follow-up with the consumer is not possible.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• 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.; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6727574
• MDR Text Key: 80520646
• Report Number: 2951250-2017-02580
• 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: foreign,other
• Type of Report: Initial
• Report Date: 07/20/2017

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: Physician
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/20/2017
• 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: 43 YR