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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); Thyroid Problems (2102); Tinnitus (2103); Visual Impairment (2138); Hot Flashes/Flushes (2153); Arthralgia (2355); Depression (2361); Heavier Menses (2666)

Event Date 06/07/2010

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(4) on (b)(6) 2017.This spontaneous case was reported by a consumer and describes the occurrence of abdominal pain lower ("low abdominal pain") and depression ("severe depression") in a (b)(6) -year-old female patient who had essure (batch no.700547) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced abdominal pain lower (seriousness criterion medically significant), depression (seriousness criterion disability), hot flush ("enormous hot flushes"), arthralgia ("joint pain"), myalgia ("muscle pain"), eczema ("eczema"), fatigue ("enormous and persistent fatigue"), visual impairment ("important vision decrease"), tinnitus ("tinnitus"), tachycardia paroxysmal ("bout of tachycardia"), dyspnoea exertional ("breathless at the slightest effort") and hyperhidrosis ("excessive sweats in whole body leading to isolation").On an unknown date, the patient experienced disturbance in attention ("lack of concentration") and menorrhagia ("more abundant menstruations").The patient was treated with antidepressants.At the time of the report, the abdominal pain lower, depression, hot flush, arthralgia, myalgia, eczema, fatigue, visual impairment, tinnitus, tachycardia paroxysmal, dyspnoea exertional, hyperhidrosis, disturbance in attention and menorrhagia outcome was unknown.The reporter provided no causality assessment for abdominal pain lower, arthralgia, depression, disturbance in attention, dyspnoea exertional, eczema, fatigue, hot flush, hyperhidrosis, menorrhagia, myalgia, tachycardia paroxysmal, tinnitus and visual impairment with essure.The reporter commented: impossibility to work full time due to fatigue and antidepressive treatment (disability class 1).Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6) kgs.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-oct-2017: quality-safety evaluation of ptc.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 10-oct-2017 for the following meddra preferred term: abdominal pain lower.The analysis in the global safety database revealed 577 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 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 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: 6979065
• MDR Text Key: 90290190
• Report Number: 2951250-2017-05454
• 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 Model Number: ESS305
• Device Lot Number: 700547
• 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
• Patient Age: 51 YR
• Patient Weight: 85