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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a healthcare professional and describes the occurrence of pelvic pain ("intermittent pelvic pain, especially when seated") in a 59 year-old female patient who had essure inserted.Additional non-serious events are detailed below.As concurrent condition the report mentioned endometriosis.On (b)(6) 2009, the patient had essure inserted.On unknown date she experienced pelvic pain (seriousness criterion intervention required) and arthralgia ("joint pain").The patient was treated with surgery (laparoscopy and.Extended total hysterectomy on (b)(6) 2024).Essure was removed on (b)(6) 2024.No causality assessment was received for essure with regard to pelvic pain or arthralgia.The reporter commented: adnexectomy via laparoscopy in 2013.Esssure removal at patient's request: on (b)(6) 2024 laparoscopy and extended hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 22.491 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 pelvic pain ("intermittent pelvic pain, especially when seated") in a 59 year-old female patient who had essure inserted.Additional non-serious events are detailed below.As concurrent condition the report mentioned endometriosis.On (b)(6) 2009, the patient had essure inserted.Essure was removed on (b)(6) 2024.On unknown date she experienced pelvic pain (seriousness criterion intervention required) and arthralgia ("joint pain").The patient was treated with surgery (laparoscopy and.Extended total hysterectomy on (b)(6) 2024).No causality assessment was received for essure with regard to pelvic pain or arthralgia.The reporter commented: adnexectomy via laparoscopy in 2013.Esssure removal at patient's request: on (b)(6) 2024 laparoscopy and extended hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 22.491 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: 18742781
• MDR Text Key: 335786403
• Report Number: 2951250-2024-00140
• 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: 02/22/2024

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: 59 YR
• Patient Sex: Female
• Patient Weight: 65 KG