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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pelvic Inflammatory Disease (2000)

Event Type  Injury  

Event Description

This spontaneous case was reported by a healthcare professional and describes the occurrence of hydrosalpinx ("the patient suffers from right hydrosalpinx") in a 52 year-old female patient who had essure inserted.The patient had a medical history of tonsillectomy, appendectomy and caesarean section.As concurrent condition the report mentioned gastroesophageal reflux.Essure was removed on (b)(6) 2023.On an unknown date, the patient had essure inserted.On an unknown date she experienced hydrosalpinx (seriousness criterion intervention required).The patient was treated with surgery (essure removal by bilateral salpingectomy).No causality assessment was received for essure with regard to hydrosalpinx.The reporter commented: essure was removed at patient's request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 20.703 kg/sqm.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.

Manufacturer Narrative

This spontaneous case was reported by a healthcare professional and describes the occurrence of hydrosalpinx ("the patient suffers from right hydrosalpinx") in a 52 year-old female patient who had essure inserted.The patient had a medical history of tonsillectomy, appendectomy and caesarean section.As concurrent condition the report mentioned gastroesophageal reflux.Essure was removed on (b)(6)2023.On an unknown date, the patient had essure inserted.On an unknown date she experienced hydrosalpinx (seriousness criterion intervention required).The patient was treated with surgery (essure removal by bilateral salpingectomy).No causality assessment was received for essure with regard to hydrosalpinx.The reporter commented: essure was removed at patient's request.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 20.703 kg/sqm.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 reported complaint reason.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: 21-feb-2024: quality safety evaluation of ptc.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: 18737697
• MDR Text Key: 335734322
• Report Number: 2951250-2024-00135
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2024
• 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): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 53 KG