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

Model Number	ESS305
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4) medical device removal "[medical device removal]" , musculoskeletal pain "[musculoskeletal pain]" , debilitating fatigue "[fatigue]".Case narrative: the below report was received by health authority ansm (reference number: (b)(4) on 31-aug-2026.This spontaneous case was originally reported by a consumer and describes the occurrence of medical device removal ("medical device removal") in a 58 year-old female patient who had essure inserted (lot no.774386) for female sterilization.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2011, the patient had essure inserted.In 2024 she experienced fatigue ("debilitating fatigue").On unknown date she experienced musculoskeletal pain ("musculoskeletal pain").On (b)(6) 2026 she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.At the time of the report, the outcomes for these events were unknown.No causality assessment was received for essure with regard to musculoskeletal pain, fatigue or medical device removal.The reporter commented: musculoskeletal pain and intense, debilitating fatigue for the past two years with no diagnosis despite numerous examinations.Patient's current status: removed 3 days ago actions taken to treat the patient in the healthcare facility: not specified.Case comments: a technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this 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: 50579135
• Report Number: 2951250-2026-00273
• Device Sequence Number: 10196496
• 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
• Device Implanted Year: 2011
• Device Explanted Year: 2026
• 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
• Device Lot Number: 774386
• 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: 09/04/2026
• 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: Required Intervention
• Patient Sex: Female