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 Abdominal Pain (1685); Diarrhea (1811); Fainting (1847); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Memory Loss/Impairment (1958); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Abnormal Vaginal Discharge (2123); Tingling (2171); Dizziness (2194); Myalgia (2238); Urinary Frequency (2275); Vascular System (Circulation), Impaired (2572); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (b)(6) on 09-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of menorrhagia ("heavy menstrual periods") in a (b)(6) 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.In 2009, the patient experience dizziness, feeling of light-headedness, absence of nasal discharge, i.E.Dry nose, heavy menstrual periods, bleeding between periods, abundant translucent vaginal discharge, loss of feeling of urge to urinate or inability to hold in urine, frequent urge to urinate, loss of libido, swollen abdomen, inflammation of pudendal nerve, aggravation of symptoms during ovulation, just before periods and during periods, weight gain, chronic fatigue, kidney pain, tendon pain, joint and muscle pain, back ache, difficulty holding the telephone for long periods, ligament pains in abdomen and hips, feeling of head in a vice, trigeminal neuritis, tingling in extremities, feet and hands, nervous tics, fasciculation, muscle spasms, feeling of heaviness in legs and of poor blood circulation, tooth pain and fibromyalgic pain, dry eyes., anxiety, fogginess and difficulty thinking of several things at once, memory loss and headaches, hair loss, dry skin and itching, stomach aches, nausea, diarrhoea, bloating, gas, noises in stomach, food not completely digested in stools and constipation.It was reported that examinations were normal.Removal of essure inserts was scheduled for (b)(6) 2017.The reporter provided no causality assessment for events with essure.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 10-aug-2017 for the following meddra preferred terms: - menorrhagia - the analysis in the global safety database revealed 431 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 these meddra pts.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: 6826740
• MDR Text Key: 83876181
• Report Number: 2951250-2017-03199
• 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: 08/29/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/29/2017
• 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