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 Code	Pelvic Pain (4865)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4).Chronic, debilitating pain "[pelvic pain female]".Recurrent joint pain "[joint pain]".Generalized flare-up of osteoarthritis "[generalized osteoarthritis]".Dry mucous membranes "[mucosal dryness]".Asthenia "[asthenia]" case narrative: the below report was received by health authority ansm (reference number: (b)(4)) on 18-sep-2026.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("chronic, debilitating pain") in a 43 year-old female patient who had essure inserted 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) 2015, the patient had essure inserted.In 2016 she experienced pelvic pain (seriousness criterion medically important), arthralgia ("recurrent joint pain"), osteoarthritis ("generalized flare-up of osteoarthritis"), mucosal dryness ("dry mucous membranes") and asthenia ("asthenia").The patient was treated with surgery (planned total hysterectomy and bilateral salpingectomy.).Essure treatment was not changed.At the time of the report, the pelvic pain and asthenia had not resolved.The outcomes for arthralgia, osteoarthritis and mucosal dryness were unknown.No causality assessment was received for essure with regard to arthralgia, pelvic pain, osteoarthritis, mucosal dryness or asthenia.The reporter commented: period of occurrence: 2016 to present.Surgical removal is planned: total hysterectomy and bilateral salpingectomy.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: 50851363
• Report Number: 2951250-2026-00287
• Device Sequence Number: 21206784
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 09/18/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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