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 Problems Abdominal Pain (1685); Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The below report was received by health authority ansm (reference number: (b)(4).On 16-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of back pain ("disabling lower back pain") and abdominal pain ("abdominal pain") in a 40 year-old 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.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2014, she experienced back pain (seriousness criterion medically important), abdominal pain (seriousness criterion medically important), fatigue ("fatigue"), thyroid disorder ("thyroid disorders"), anxiety ("anxiety"), deafness neurosensory ("sensorineural disorders"), arthropathy ("joint disorder") and muscle disorder ("muscle disorder").Essure treatment was not changed.At the time of the report, none of the events had resolved.The reporter considered abdominal pain, anxiety, arthropathy, back pain, deafness neurosensory, fatigue, muscle disorder and thyroid disorder to be related to essure administration.The reporter commented: events resulting in sick leave, medical wandering, surgeries secondary to the side effects of the essure devices.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 55 kg.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

The below report was received by health authority ansm (reference number: (b)(4)) on 16-feb-2024.The most recent information was received on 23-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of back pain ("disabling lower back pain") and abdominal pain ("abdominal pain") in a 40 year-old 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.On (b)(6) 2009, the patient had essure inserted.In (b)(6) 2014 she experienced back pain (seriousness criterion medically important), abdominal pain (seriousness criterion medically important), fatigue ("fatigue"), thyroid disorder ("thyroid disorders"), anxiety ("anxiety"), deafness neurosensory ("sensorineural disorders"), arthropathy ("joint disorder") and muscle disorder ("muscle disorder").Essure treatment was not changed.At the time of the report, none of the events had resolved.The reporter considered abdominal pain, anxiety, arthropathy, back pain, deafness neurosensory, fatigue, muscle disorder and thyroid disorder to be related to essure administration.The reporter commented: events resulting in sick leave, medical wandering, surgeries secondary to the side effects of the essure devices.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 55 kg.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: 23-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: 18749280
• MDR Text Key: 335932998
• Report Number: 2951250-2024-00149
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 02/23/2024
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Weight: 55 KG