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 Genital Bleeding (4507)

Event Date 12/01/2023

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a consumer (subsequently medically confirmed) and describes the occurrence of genital haemorrhage ("excessive bleeding / i was just seen by a ob for some excessive bleeding / bleeding for approximately 10 days") in an adult female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2013, the patient had essure inserted.In (b)(6) 2023 she experienced genital haemorrhage (seriousness criterion intervention required).Essure was removed on (b)(6) 2024.On unknown date she experienced night sweats ("night sweats"), anxiety ("a lot of anxiety"), mood swings ("mood swings") and menopausal symptoms ("premenopausal symptoms").The patient was treated with medroxyprogesterone as well as surgery (essure removal (b)(6) 2024).At the time of the report, the genital haemorrhage was resolving.The reporter considered anxiety, genital haemorrhage, menopausal symptoms, mood swings and night sweats to be related to essure administration.The reporter commented: placed essure in 2013-2014, lot number unknown, patient was diagnosed with essure syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound pelvis] (date unknown): the ultrasound showed no cysts.He was diagnosed with essure syndrome.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.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 could not be conducted, as no sample was available 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 originally reported by a consumer (subsequently medically confirmed) and describes the occurrence of genital haemorrhage ("excessive bleeding/i was just seen by a ob for some excessive bleeding/bleeding for approximately 10 days") in an adult female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.There was no information on the patient's medical history or concurrent conditions.In 2013, the patient had essure inserted.In (b)(6) 2023, she experienced genital haemorrhage (seriousness criterion intervention required).Essure was removed on (b)(6) 2024.On unknown date she experienced night sweats ("night sweats"), anxiety ("a lot of anxiety"), mood swings ("mood swings") and menopausal symptoms ("premenopausal symptoms").The patient was treated with medroxyprogesterone as well as surgery (essure removal on (b)(6) 2024).At the time of the report, the genital haemorrhage was resolving.The reporter considered anxiety, genital haemorrhage, menopausal symptoms, mood swings and night sweats to be related to essure administration.The reporter commented: placed essure in 2013-2014.Lot number unknown.Patient was diagnosed with essure syndrome.Diagnostic results (normal ranges are provided in parenthesis if available): [ultrasound pelvis] (date unknown): the ultrasound showed no cysts.He was diagnosed with essure syndrome.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: 29-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: 18766092
• MDR Text Key: 336053769
• Report Number: 2951250-2024-00155
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 02/29/2024
• 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: 43 YR
• Patient Sex: Female