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

Model Number	ESS305
Medical Device Problem Codes	Difficult to Insert (1316); Expulsion (2933); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Pelvic Pain (4865)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4).Severe pelvic floor pain "[pelvic pain female]".Essure device had shifted from my ovary to my uterus "[partial expulsion of device]".Unilateral left essure placement."[device insertion failed]".Case narrative: the below report was received by health authority (b)(6) (reference number: (b)(4)) on 21-sep-2026.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("severe pelvic floor pain.") in a 61 year-old female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device insertion failed ("unilateral left essure placement.") there was no information on the patient's medical history or concurrent conditions.On an unknown date, the patient had essure inserted.On (b)(6) 2024 she experienced device expulsion ("essure device had shifted from my ovary to my uterus").In 2024 she experienced pelvic pain (seriousness criterion medically important).At the time of the report, the pelvic pain had not resolved.The outcome of device expulsion was unknown.The reporter considered device expulsion and pelvic pain to be related to essure administration.The reporter commented: unilateral left essure placement.Female patient's current condition: i can no longer tolerate these episodes actions taken to treat the patient in the healthcare facility:.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 63 kg."[ultrasound scan]" on (b)(6) 2024: uterus: length: 50 mm; width: 41 mm; thickness: 24 mm; location: normally situated; echostructure: homogeneous; cavity and mucosa: atrophic endometrium but cavity occupied by essure; endometrial thickness: not measurable.Ovaries: right ovary: seen, menopausal - dimensions: 22/8 mm; left ovary: seen, menopausal; rectouterine pouch: normal.Conclusion: intracavitary images probably corresponding to the essure device.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: 50882072
• Report Number: 2951250-2026-00291
• Device Sequence Number: 10755011
• 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
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2026
• Initial 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
• Patient Weight: 138 LB