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

Model Number ESS305

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rheumatoid Arthritis (1724); Cataract (1766); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Incontinence (1928); Itching Sensation (1943); Muscular Rigidity (1968); Nausea (1970); Pain (1994); Swelling (2091); Tinnitus (2103); Abnormal Vaginal Discharge (2123); Vertigo (2134); Visual Disturbances (2140); Dysphasia (2195); Arthralgia (2355); Neck Pain (2433); Sleep Dysfunction (2517); Weight Changes (2607)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4).This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pains") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unspecified date, the patient experienced tinnitus, vertigos, inebriation sensation, loss of balance, hemorrhagic and painful periods, vaginal discharge, pelvic pains, urinary incontinence, impossibility to not urinate, loss of libido, swollen abdomen, weight gain, nauseas, swollen colon, chronic fatigue, insomnia, depression, joint pains on back, hand, feet, hips, neck, muscular rigidity, muscular weakness, psoriasis increased, rheumatism psoriasis, migraines, jawbone pain, fibromyalgia pain, vision disorders, diplopia, accommodation difficulty, retro capsular cataract, crying eyes, concentration disorders, speech disorders, loss of hair, itching, face spots, neck swelling, diarrheas, loss of self-esteem, bile taste in mouth, and bad mouth smell.The patient was treated with surgery (essure was removed on (b)(6) 2017).At the time of the report, the reported events outcome was unknown.No causality between essure device and the reported events was provided.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 28-nov-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 8236 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 follow-up information is not possible with regulatory authority.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
• MDR Report Key: 7062911
• MDR Text Key: 93061192
• Report Number: 2951250-2017-09130
• 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: 11/28/2017

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: 11/24/2017
• Initial Date FDA Received: 11/28/2017
• 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