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

Model Number ESS205

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

Patient Problems Fatigue (1849); Visual Impairment (2138); Dizziness (2194); Myalgia (2238); Arthralgia (2355); Heavier Menses (2666)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(6), reference number: (b)(4)) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic periods") in a female patient who had essure (batch no.082456) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2003, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), dizziness ("dizziness"), myalgia ("muscular pain"), arthralgia ("joint pain"), headache ("violent headache") and visual impairment ("vision disorders").The patient was treated with surgery (essure was removed on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, fatigue, dizziness, myalgia, arthralgia, headache and visual impairment outcome was unknown.The reporter provided no causality assessment for arthralgia, dizziness, fatigue, headache, menorrhagia, myalgia and visual impairment with essure.The list of similar cases 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) 2018 for the following meddra preferred terms: menorrhagia ¿ analysis in the global safety database revealed 1067 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 these meddra pt.Further company follow-up with the regulatory authority is not possible.Incident: at the time of reporting, 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.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: (b)(4)) on 24-may-2018.The most recent information was received on 15-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("hemorrhagic periods") in a female patient who had essure (batch no.082456-invalid) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2003, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), dizziness ("dizziness"), myalgia ("muscular pain"), arthralgia ("joint pain"), headache ("violent headache") and visual impairment ("vision disorders").The patient was treated with surgery (essure was removed on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia, fatigue, dizziness, myalgia, arthralgia, headache and visual impairment outcome was unknown.The reporter provided no causality assessment for arthralgia, dizziness, fatigue, headache, menorrhagia, myalgia and visual impairment with essure.The list of similar cases 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) 2018 for the following meddra preferred terms: menorrhagia ¿ analysis in the global safety database revealed 1.297 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 these meddra pt.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 15-jun-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, 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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7544311
• MDR Text Key: 109272543
• Report Number: 2951250-2018-02381
• 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,Followup
• Report Date: 06/18/2018

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: Health Professional
• Device Model Number: ESS205
• Device Lot Number: 082456-INVALID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 05/25/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention