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); Pain (1994); Tinnitus (2103); Loss of Vision (2139); Visual Disturbances (2140); Depression (2361)

Event Date 06/01/2015

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 04-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of back pain ("back pains"), auditory disorder ("acoustic disorders"), blindness ("loss of vision") and depression ("severe depression") in a (b)(6)-year-old female patient who had essure (batch no.C38211) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced back pain (seriousness criteria disability and medically significant), auditory disorder (seriousness criterion disability), blindness (seriousness criteria disability and medically significant), depression (seriousness criterion disability), musculoskeletal pain ("muscular pains and joint pains"), amnesia ("loss of memory"), visual impairment ("vision decreased"), tinnitus ("tinnitus") and fatigue ("chronic fatigue").The patient was treated with zolpidem, diazepam, fluoxetine hydrochloride (prozac), panadeine co (dafalgan codeine), ibuprofen (spifen), sulbutiamine (arcalion), pantoprazole and alternative therapy.At the time of the report, the back pain, auditory disorder, blindness, depression, musculoskeletal pain, amnesia, visual impairment, tinnitus and fatigue outcome was unknown.The reporter provided no causality assessment for amnesia, auditory disorder, back pain, blindness, depression, fatigue, musculoskeletal pain, tinnitus and visual impairment with essure.The reporter commented: since (b)(6) 2017, she was on disability.Back pains and acoustic disorders, loss of vision, loss of memory, she was in severe depression that took her away from social and normal life.She underwent 4 infiltrations in the back, she wore a medical corset for 1 year and she took a heavy treatment that took her away from social life.She began process for disabled official card and she was completely dependent of her entourage.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be (b)(6).Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-sep-2017: quality-safety evaluation of ptc 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) 2017 for the following meddra pt: back pain: n° 338 cases (excluding this case).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 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: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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. shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6897162
• MDR Text Key: 87483802
• Report Number: 2951250-2017-04054
• 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: 09/27/2017

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: 03/31/2017
• Device Model Number: ESS305
• Device Lot Number: C38211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2017
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 45 YR
• Patient Weight: 80