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

The below report was received by health authority ansm (reference number: (b)(4)) on 20-feb-2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("sharp pains") 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.Essure was removed on (b)(6) 2014.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), urticaria ("hives"), heavy menstrual bleeding ("haemorrhagic periods"), bone pain ("pain in her bones"), arthralgia ("joints"), tooth disorder ("problems with her teeth"), visual impairment ("; problems with her vision"), dyspnoea ("shortness of breath"), chest pain ("painful feeling of pressure in her chest"), burnout syndrome ("burn out"), fatigue ("physical exhaustion") and emotional disorder ("emotional exhaustion").The patient was treated with surgery (essure removal :(b)(6) 2014).At the time of the report, the outcomes for pelvic pain, urticaria, heavy menstrual bleeding, bone pain, arthralgia, tooth disorder, visual impairment, dyspnoea, chest pain, burnout syndrome and fatigue were unknown.No causality assessment was received for essure with regard to pelvic pain, urticaria, heavy menstrual bleeding, bone pain, arthralgia, tooth disorder, visual impairment, dyspnoea, chest pain, burnout syndrome, fatigue or emotional disorder.The reporter commented: onset period january 2015.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 90 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 (b)(6) 2024.The most recent information was received on (b)(6) 2024.This spontaneous case was originally reported by a consumer and describes the occurrence of pelvic pain ("sharp pains") 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.On an unknown date, the patient had essure inserted.On unknown dates she experienced pelvic pain (seriousness criterion intervention required), urticaria ("hives"), heavy menstrual bleeding ("haemorrhagic periods"), bone pain ("pain in her bones"), arthralgia ("joints"), tooth disorder ("problems with her teeth"), visual impairment ("; problems with her vision"), dyspnoea ("shortness of breath"), chest pain ("painful feeling of pressure in her chest"), burnout syndrome ("burn out"), fatigue ("physical exhaustion") and emotional disorder ("emotional exhaustion").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2014.At the time of the report, the outcomes for pelvic pain, urticaria, heavy menstrual bleeding, bone pain, arthralgia, tooth disorder, visual impairment, dyspnoea, chest pain, burnout syndrome and fatigue were unknown.No causality assessment was received for essure with regard to pelvic pain, urticaria, heavy menstrual bleeding, bone pain, arthralgia, tooth disorder, visual impairment, dyspnoea, chest pain, burnout syndrome, fatigue or emotional disorder.The reporter commented: onset period (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): body weight was reported to be 90 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: 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: 18768743
• MDR Text Key: 336123280
• Report Number: 2951250-2024-00158
• 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: 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 Sex: Female
• Patient Weight: 90 KG