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

Model Number ESS305

Device Problem Insufficient Information (3190)

Patient Problems Asthma (1726); Dyspnea (1816); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Pain (1994); Tinnitus (2103); Burning Sensation (2146)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on 29-sep-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pains") in a female patient who had essure (batch no.C26933) inserted.The occurrence of additional non-serious events is detailed below.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), tinnitus ("tinnitus"), fatigue ("fatigue"), dyspnoea ("out of breath"), dyspepsia ("digestive disorders"), allergy to metals ("titanium and nickel allergy"), eczema ("eczema"), burning sensation ("burning"), cystitis ("cystitis"), fungal infection ("mycosis"), headache ("headaches") and asthma ("asthma").The patient was treated with surgery (removal of essure was planned).Essure treatment was not changed.At the time of the report, the pelvic pain, tinnitus, fatigue, dyspnoea, dyspepsia, allergy to metals, eczema, burning sensation, cystitis, fungal infection, headache and asthma outcome was unknown.The reporter provided no causality assessment for allergy to metals, asthma, burning sensation, cystitis, dyspepsia, dyspnoea, eczema, fatigue, fungal infection, headache, pelvic pain and tinnitus with essure.The reporter commented: the event happened at the home of the patient.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 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 medra preferred term.In this particular case a search in the database was performed on (b)(6) 2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed (b)(4) 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 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: 6982881
• MDR Text Key: 90395225
• Report Number: 2951250-2017-05517
• 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: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C26933
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2017
• 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