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

Model Number	ESS305
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	09/09/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer case number: (b)(4).Itching "[itching]" migraines "[migraine]" sight disorder "[visual disturbance]" excessive perspiration "[perspiration excessive]" tachycardia "[tachycardia]".Case narrative: the below report was received by health authority ansm (reference number: (b)(4) on 18-sep-2026.The most recent information was received on 24-sep-2026.This spontaneous case was originally reported by a consumer and describes the occurrence of pruritus ("itching") in a 38-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)-2011, the patient had essure inserted.On (b)(6)-2012, 367 days after essure insertion, she experienced pruritus (seriousness criterion medically important), migraine ("migraines"), visual impairment ("sight disorder"), hyperhidrosis ("excessive perspiration") and tachycardia ("tachycardia").At the time of the report, none of the events had resolved.No causality assessment was received for essure with regard to migraine, pruritus, visual impairment, hyperhidrosis or tachycardia.The reporter commented: current state of the patient: persistent disorders actions taken to treat the patient in the healthcare facility: not specified.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 106 kg.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly; no signal was observed with regard to the reason for the reported complaint.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 24-sep-2026: quality safety evaluation of product technical complaint.Case comments: based on the available information, a review of our complaint records and other relevant data was 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: 50874452
• Report Number: 2951250-2026-00290
• Device Sequence Number: 21501421
• 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
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 09/23/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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: 233 LB