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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia') and iron deficiency anaemia ('anaemia from chronic blood loss') in an adult female patient who had essure inserted for female sterilization.The patient's medical history included vaginal bleeding, menorrhagia, anemia, endometrial thickening, dysfunctional uterine bleeding and nabothian cyst.In 2010, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria hospitalization, medically significant and intervention required) and iron deficiency anaemia (seriousness criterion medically significant).The patient was treated with surgery (lavh, bilateral salpingectomy, ablation) and blood transfusion.Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia and iron deficiency anaemia outcome was unknown.The reporter considered iron deficiency anaemia and menorrhagia to be related to essure.The reporter commented: discrepancy noted at date of removal (b)(6) 2018.Quality-safety evaluation of ptc: unable to confirm complaint.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 reported by a lawyer and describes the occurrence of menorrhagia ('menorrhagia') and iron deficiency anaemia ('anaemia from chronic blood loss') in an adult female patient who had essure inserted for female sterilization.The patient's medical history included vaginal bleeding, menorrhagia, anemia, endometrial thickening, dysfunctional uterine bleeding and nabothian cyst.In 2010, the patient had essure inserted.On an unknown date, the patient experienced menorrhagia (seriousness criteria hospitalization, medically significant and intervention required) and iron deficiency anaemia (seriousness criterion medically significant).The patient was treated with surgery (lavh, bilateral salpingectomy, ablation) and blood transfusion.Essure was removed on (b)(6) 2018.At the time of the report, the menorrhagia and iron deficiency anaemia outcome was unknown.The reporter considered iron deficiency anaemia and menorrhagia to be related to essure.The reporter commented: discrepancy noted at date of removal (b)(6) 2018.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-aug-2020: 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
• MDR Report Key: 10381255
• MDR Text Key: 202193554
• Report Number: 2951250-2020-12914
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention