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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Syncope (1610); Chest Pain (1776); Dry Eye(s) (1814); Emotional Changes (1831); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Swelling (2091); Tinnitus (2103); Visual Disturbances (2140); Hot Flashes/Flushes (2153); Dizziness (2194); Urinary Frequency (2275); Anxiety (2328); Arthralgia (2355); Depression (2361); Neck Pain (2433); Sweating (2444); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of back pain ("pain in lower back"), in a female patient who had essure 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 pain in lower back (seriousness criterion medically significant / intervention required), difficult insertion, painful, painful intercourse, loss of libido, muscle pain, pain in joints, headache, migraine, pain in chest, pain in legs, pain in neck, swollen eyes, lips and face, early menopause, hot flashes, night sweats, excessive sweating during the day, fatigue, insomnia, dry skin, hair and eyes, vision problems, depression, urinary infection, excessive urinating, tailbone pain, nausea, extreme dizziness, sensation of stimulations through the entire body, brain fog extreme, forgetfulness, delaying behavior, tinnitus, mental disorder, metal taste, lower abdomen restlessness butterflies, spasms, anxiety and panic attacks, mood swings, black-outs and fainting, postraumatic stress disorder, changed into a lazy, slow person and always confused.Essure was removed on (b)(6) 2016, along with her oviducts and part of her uterus.Around half a year later patient can say that all her complaints are gone.The reporter provided no causality assessment for the events with essure.The list of device similar incidents 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 24-aug-2017 for the following meddra preferred term: back pain.The analysis in the global safety database revealed 320 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.Incident.No lot number or sample available for investigation.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: 6857430
• MDR Text Key: 85853254
• Report Number: 2951250-2017-03568
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention