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

Model Number ESS305

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

Patient Problems Fatigue (1849); Headache (1880); Pain (1994); Myalgia (2238); Malaise (2359); Depression (2361); Weight Changes (2607)

Event Date 06/18/2013

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ((b)(4), reference number: (b)(4)) on 15-may-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure (batch no.A78078) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), depressed mood ("negative mood") and depression ("depression").On an unknown date, the patient experienced malaise ("malaise"), migraine ("migraines"), musculoskeletal pain ("muscle and joint pain"), fatigue ("overwhelming fatigue") and weight increased ("weight increasing").The patient was treated with surgery (uterus and fallopian tubes ablation scheduled to (b)(6) 2018).At the time of the report, the pelvic pain, depressed mood, depression, malaise, migraine, musculoskeletal pain, fatigue and weight increased had not resolved.The reporter provided no causality assessment for depressed mood, depression, fatigue, malaise, migraine, musculoskeletal pain, pelvic pain and weight increased 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 (pt).In this particular case a search in the global safety database was performed on 18-may-2018 for the following meddra pt (excluding this case): pelvic pain: 11296 cases were identified.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 or 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 in a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (ansm, reference number: r1807273) on (b)(6) 2018.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure (batch no.A78078) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), depressed mood ("negative mood") and depression ("depression").On an unknown date, the patient experienced malaise ("malaise"), migraine ("migraines"), musculoskeletal pain ("muscle and joint pain"), fatigue ("overwhelming fatigue") and weight increased ("weight increasing").The patient was treated with surgery (uterus and fallopian tubes ablation scheduled to (b)(6) 2018).Essure was removed.At the time of the report, the pelvic pain, depressed mood, depression, malaise, migraine, musculoskeletal pain, fatigue and weight increased had not resolved.The reporter provided no causality assessment for depressed mood, depression, fatigue, malaise, migraine, musculoskeletal pain, pelvic pain and weight increased 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 (pt).In this particular case a search in the global safety database was performed on (b)(6) 2018 for the following meddra pt (excluding this case): pelvic pain: 11.560 cases were identified.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 13-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 in 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: 7525446
• MDR Text Key: 108630772
• Report Number: 2951250-2018-02252
• 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: 06/14/2018

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: 12/15/2015
• Device Model Number: ESS305
• Device Lot Number: A78078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention