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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Fatigue (1849); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Myalgia (2238); Arthralgia (2355)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 26-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") and autoimmune hepatitis ("auto-immune hepatitis") in a female patient who had essure (batch no.C61996) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), autoimmune hepatitis (seriousness criterion medically significant), fatigue ("fatigue"), myalgia ("muscular pain"), arthralgia ("joint pain"), nausea ("nausea"), abdominal pain upper ("stomach ache"), diarrhoea ("diarrhoea"), cardiac murmur ("heart murmur"), formication ("formication in arm, feet, buttock"), amnesia ("memory loss"), aphasia ("searching for words") and hyperhidrosis ("excessive sweats").The patient was treated with surgery (pending for surgery).At the time of the report, the pelvic pain, autoimmune hepatitis, fatigue, myalgia, arthralgia, nausea, abdominal pain upper, diarrhoea, cardiac murmur, formication, amnesia, aphasia and hyperhidrosis outcome was unknown.The reporter provided no causality assessment for abdominal pain upper, amnesia, aphasia, arthralgia, autoimmune hepatitis, cardiac murmur, diarrhoea, fatigue, formication, hyperhidrosis, myalgia, nausea and pelvic pain with essure.Diagnostic results: pending for allergy test on metal components of 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 09-oct-2017 for the following meddra preferred term: pelvic pain- the analysis in the global safety database revealed 4.820 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.Quality-safety evaluation of ptc: unable to confirm complaint.Further company follow-up with the consumer or regulatory authority is not possible.Most recent follow-up information incorporated above includes: on 6-oct-2017: 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: 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: 6979103
• MDR Text Key: 90298031
• Report Number: 2951250-2017-05457
• 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: 10/26/2017

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: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: ESS305
• Device Lot Number: C61996
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention