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); Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Depression (2361); Foreign Body In Patient (2687); Pelvic Pain (4865)
Date of Event	09/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Bayer case number: (b)(4).Pelvic pain "[pelvic pain female]".The implants have migrated out of the fallopian tubes "[device migration]".Pain in the iliac fossae, predominantly on the left "[iliac fossa pain]".Significant sleep disorders "[sleep disorder]", wakefulness "[wakefulness]", sensations of electric shocks in the legs, mainly at night "[electric shock sensation]".Stiffness of the pelvis with restriction of certain daily movements (putting on my socks, for example); "[muscle stiffness]", belly ache; "[belly ache]", diffuse joint pain "[joint pain]", dry skin "[dry skin]", depressive episode in the context of chronic pain."[depressive episode]".Case narrative: the below report was received by health authority ansm (reference number: (b)(4)) on 21-sep-2026.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in an adult female patient who had essure inserted (lot no.624104) for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2007, the patient had essure inserted.On (b)(6) 2026, 6955 days after essure insertion, she experienced pelvic pain (seriousness criterion intervention required), device dislocation ("the implants have migrated out of the fallopian tubes"), abdominal pain lower ("pain in the iliac fossae, predominantly on the left"), sleep disorder ("significant sleep disorders"), poor quality sleep ("wakefulness"), electric shock sensation ("sensations of electric shocks in the legs, mainly at night"), musculoskeletal stiffness ("stiffness of the pelvis with restriction of certain daily movements (putting on my socks, for example);"), abdominal pain ("belly ache;"), arthralgia ("diffuse joint pain"), dry skin ("dry skin") and depression ("depressive episode in the context of chronic pain.").The patient was treated with surgery (total hysterectomy).Essure treatment was not changed.At the time of the report, none of the events had resolved.No causality assessment was received for essure with regard to device dislocation, abdominal pain lower, abdominal pain, dry skin, pelvic pain, sleep disorder, poor quality sleep, electric shock sensation, musculoskeletal stiffness, arthralgia or depression.The reporter commented: the implants are still present, even though i had a total hysterectomy.The implants have migrated out of the fallopian tubes and are still present.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 74 kg.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: 50895323
• Report Number: 2951250-2026-00292
• Device Sequence Number: 16142841
• 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: 2007
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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 Expiration Date: 03/31/2009
• Device Model Number: ESS305
• Device Lot Number: 624104
• 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: 09/21/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 09/25/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 04/30/2007
• 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
• Patient Weight: 162 LB