MAUDE Adverse Event Report: Bayer Pharma AG ESSURE; Transcervical Contraceptive Tubal Occlusion Device

Model Number	ESS305
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Headache (1880)
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number:(b)(4).Stomach pains during menstruation "[pain menstrual]".Severe headache "[headache]".Case narrative: the below report was received by health authority ansm (reference number: r2624455) on (b)(6) 2026.This spontaneous case was originally reported by a consumer and describes the occurrence of dysmenorrhoea ("stomach pains during menstruation") in an adult female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On unknown dates she experienced dysmenorrhoea (seriousness criterion medically important) and headache ("severe headache").At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to headache or dysmenorrhoea.The reporter commented: patient¿s current status: not specified actions taken to treat the patient in the healthcare facility: not specified.Case comments: based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.In case a sample is received, the investigation might lead to destruction of the sample if required to perform a proper analysis.

• Brand Name: ESSURE
• Common Device Name: 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: janice miller ; 100 bayer blvd, p.o. box 915; whippany 07981--091 ; +1(862)404-3698
• MDR Report Key: 50586217
• Report Number: 2951250-2026-00277
• Device Sequence Number: 16008870
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: 10888853003051
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: P020014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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
• Operator of Device: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/05/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female