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 Insufficient Information (4580)

Event Type  Injury  

Event Description

These female patients were identified, during an active online listening program.The patients had essure inserted.The case describes, the occurrence of injury ("essure took ten years of my life, it was awful").There was no information on the patient's medical history or concurrent conditions.On an unknown date, the patients had essure inserted.On unknown dates, they experienced injury (seriousness criterion medically important).At the time of the report, the outcome of the event was unknown.No causality assessment was received, for essure with regard to injury.The reporter commented: sick, disabled, their lives sometimes shattered, the victims of the essure implant case conduct their own research.Quality safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 09-feb-2024, quality safety evaluation of ptc.Further company follow-up with the reporter is not possible.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: 18701449
• MDR Text Key: 335295888
• Report Number: 2951250-2024-00105
• Device Sequence Number: 1
• Product Code: HHS
• 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,Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 02/09/2024
• 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 Sex: Female