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); Menstrual Irregularities (1959); Pain (1994); Pelvic Pain (4865); Back pain (4895)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4) pelvic pain female "[pelvic pain female]", asthenia "[asthenia]" , abdominal pain "[abdominal pain]" , muscular pain "[muscular pain]" , impaired quality of life "[impaired quality of life]", scanty menstrual periods "[hypomenorrhea]" , vaginal tenderness "[vaginal pain]" , para tubal vestigial cysts "[para tubal cyst]" , adenomyosis "[adenomyosis]" , uterine leiomyoma "[uterine leiomyoma]" , lumbar pain "[lumbar pain]".Case narrative: this spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain female") in a 44 year-old female patient who had essure inserted for female sterilization.Additional non-serious events are detailed below.The patient had a medical history of parity 4 (2001, 2003, 2006 and 2013).On (b)(6) 2016, the patient had essure inserted.In 2020 she experienced pelvic pain (seriousness criterion intervention required), asthenia ("asthenia"), abdominal pain ("abdominal pain"), myalgia (" muscular pain "), impaired quality of life ("impaired quality of life"), hypomenorrhoea ("scanty menstrual periods") and vulvovaginal pain ("vaginal tenderness").Essure was removed on (b)(6) 2025.On unknown date she experienced adnexa uteri cyst ("paratubal vestigial cysts"), adenomyosis ("adenomyosis") and back pain ("lumbar pain") and was found to have uterine leiomyoma ("uterine leiomyoma").The patient was treated with surgery (a total hysterectomy with bilateral salpingectomy).At the time of the report, the outcomes for these events were unknown.The reporter considered abdominal pain, adenomyosis, adnexa uteri cyst, asthenia, back pain, hypomenorrhoea, impaired quality of life, myalgia, pelvic pain, uterine leiomyoma and vulvovaginal pain to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): "[abdominal x-ray]" on (b)(6) 2025: essure did not reveal any residual implant fragments."[computerized tomogram]" on (b)(6)2025: revealed large disc protrusions at the two lower lumbar levels, as well as spinal canal narrowing and presences of disc arthrosis."[computerized tomogram abdomen]" on (b)(6) 2024: it was found 2 large hepatic nodular lesions, one subcapsular in segment ii and the other subcapsular in segment vii, suggestive of focal nodular hyperplasia."[magnetic resonance imaging]" on (b)(6) 2025: low back pain "[ultrasound pelvis]" on (b)(6) 2025: with no abnormality observed 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: 50943437
• Report Number: 2951250-2026-00294
• Device Sequence Number: 13373518
• 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: 2016
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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: 09/28/2026
• Supplement Date Received by Manufacturer: 10/02/2026
• Initial Report FDA Received Date: 09/30/2026
• Supplement Report FDA Received Date: 10/02/2026
• 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