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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fatigue (1849); Headache (1880); Muscle Weakness (1967); Nausea (1970); Rash (2033); Arthralgia (2355)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority(b)(4) on 03-oct-2017.The most recent information was received on 06-oct-2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("belly ache") in a female patient who had essure (b)(4) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), rash ("skin eruption"), fatigue ("generalized fatigue state"), myalgia ("muscle soreness"), arthralgia ("joint pain"), nausea ("nausea"), migraine ("migraines") and diarrhoea ("diarrhoea").The patient was treated with surgery (implant removal).Essure was removed.At the time of the report, the abdominal pain, rash, fatigue, myalgia, arthralgia, nausea, migraine and diarrhoea outcome was unknown.The reporter provided no causality assessment for abdominal pain, arthralgia, diarrhoea, fatigue, migraine, myalgia, nausea and rash with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred term.In this particular case a search in the database was performed on 09-oct-2017 for the following meddra preferred term: abdominal pain.The analysis in the (b)(4) 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.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.Company causality comment: 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 (reference number: (b)(4)) on (b)(6) 2017.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain ("belly ache") in a female patient who had essure (batch no.He011fl) inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain (seriousness criteria medically significant and intervention required), rash ("skin eruption"), fatigue ("generalized fatigue state"), myalgia ("muscle soreness"), arthralgia ("joint pain"), nausea ("nausea"), migraine ("migraines") and diarrhoea ("diarrhoea").The patient was treated with surgery (implant removal).Essure was removed.At the time of the report, the abdominal pain, rash, fatigue, myalgia, arthralgia, nausea, migraine and diarrhoea outcome was unknown.The reporter provided no causality assessment for abdominal pain, arthralgia, diarrhoea, fatigue, migraine, myalgia, nausea and rash with essure.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 (b)(6) 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: 6987882
• MDR Text Key: 90587941
• Report Number: 2951250-2017-05796
• 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: 10/02/2018

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 Expiration Date: 11/28/2018
• Device Model Number: ESS305
• Device Lot Number: HE011FL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2017
• Initial Date FDA Received: 10/30/2017
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention