MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4)) on 25-aug-2021.The most recent information was received on 31-aug-2021.This spontaneous case was originally reported by a consumer and describes the occurrence of device dislocation ("suspicion of essure migration") in a 46 year-old female patient who had essure inserted.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.An unknown time later she experienced device dislocation (seriousness criterion medically important), menstruation irregular ("very irregular menstrual periods"), memory impairment ("memory problems which worsen"), arthralgia ("joint pain"), fatigue ("severe fatigue") and feeling abnormal (" impression of having the body of a (b)(6) person") and was found to have weight increased ("big weight gain").Essure treatment was not changed.At the time of the report, the menstruation irregular, memory impairment, weight increased, arthralgia, fatigue and feeling abnormal had not resolved.The outcome of device dislocation was unknown.No causality assessment was received for essure with regard to memory impairment, weight increased, arthralgia, menstruation irregular, fatigue, feeling abnormal or device dislocation.The reporter commented: period of occurrence of events was for several years.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 91 kg.[red blood cell sedimentation rate] (date unknown): increased.[x-ray] (date unknown): suspicion of implant migration.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The following amendment was made: after internal review, events suspicion of essure migration and impression of having the body of a (b)(6) person were added.Seriousness for device was amended from non serious incident to serious incident.Lab data added,.No new follow-up information was received from the reporter.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.

• Brand Name: ESSURE
• Type of Device: 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, NJ 07981
• MDR Report Key: 18264479
• MDR Text Key: 329667236
• Report Number: 2951250-2023-03482
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Date Manufacturer Received: 08/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 91 KG