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

Model Number ESS205

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure (ess205) inserted.Additional non-serious events are detailed below.Product or product use issues identified: device failure, defect ("failure defect (incl other organ damage)").There was no information on the patient's medical history or concurrent conditions.In (b)(6) 2004, the patient had essure (ess205) inserted.In (b)(6) 2022.An unknown time later she experienced pelvic pain (seriousness criterion intervention required), abnormal uterine bleeding ("abnormal uterine bleeding"), injury ("failure defect (incl other organ damage)"), sexual dysfunction ("sexual dysfunction") and mental disorder ("psychiatric injury").The patient was treated with surgical essure removal in (b)(6) 2022 (hysterectomy and salpingectomy bilateral).At the time of the report, the outcomes for pelvic pain, abnormal uterine bleeding, injury and sexual dysfunction were unknown.The reporter considered abnormal uterine bleeding, injury, mental disorder, pelvic pain and sexual dysfunction to be related to essure (ess205) administration.The reporter commented: events have impact on lifestyle.Quality-safety evaluation of ptc: for essure (ess205): unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 31-jan-2023: report was received on 27-jan-2023 - but date cannot be earlier than most recent follow up thus entered as 31-jan-2023: case became serious incident.Essure removal via hysterectomy and salpingectomy (bilateral) in (b)(6) 2022.Psychiatric injury was added as event.Cluster id added.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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer, on behalf of a consumer and describes the occurrence of pelvic pain ("pelvic pain").In a female patient who had essure (ess205) inserted.Additional non-serious events are detailed below.Product or product use issues identified: device failure, defect ("failure defect (incl other organ damage)").There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2004, the patient had essure (ess205) inserted.Essure (ess205) was removed in (b)(6) 2022.An unknown time later, she experienced pelvic pain (seriousness criterion intervention required), abnormal uterine bleeding ("abnormal uterine bleeding"), injury ("failure defect (incl other organ damage)"), sexual dysfunction ("sexual dysfunction") and mental disorder ("psychiatric injury").The patient was treated with surgery (hysterectomy and salpingectomy (bilateral)).At the time of the report, the outcomes for pelvic pain, abnormal uterine bleeding, injury and sexual dysfunction were unknown.The reporter considered, abnormal uterine bleeding, injury, mental disorder, pelvic pain and sexual dysfunction to be related to essure (ess205) administration.The reporter commented: events have impact on lifestyle.Quality safety evaluation of ptc: for essure (ess205), 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: 16-mar-2023, 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, nj
• MDR Report Key: 16399004
• MDR Text Key: 309860161
• Report Number: 2951250-2023-00548
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS205
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• 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