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 Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tinnitus (2103); Visual Impairment (2138); Arthralgia (2355); Depression (2361); Heavier Menses (2666)

Event Date 04/01/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm ((b)(4)) on (b)(6) 2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic periods for 1 month") and ear infection ("repetitive otitis") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On (b)(6) 2015, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), ear infection (seriousness criterion medically significant), fatigue ("very severe fatigue"), depression ("depression"), tinnitus ("tinnitus"), arthralgia ("joint pain on toes and hands"), headache ("headaches") and visual impairment ("vision disorders").The patient was treated with surgery (essure removal planned for (b)(6) 2017).At the time of the report, the menorrhagia, ear infection, fatigue, depression, tinnitus, arthralgia, headache and visual impairment outcome was unknown.The reporter provided no causality assessment for arthralgia, depression, ear infection, fatigue, headache, menorrhagia, tinnitus and visual impairment with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: menorrhagia.The analysis in the global safety database revealed (b)(4)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 regulatory authority 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. lamberson ; 100 bayer blvd.; p.o. box 915; whippany 07981-0915
• MDR Report Key: 6885873
• MDR Text Key: 87174377
• Report Number: 2951250-2017-03876
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• 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: 08/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention