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 Headache (1880); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Myalgia (2238); Numbness (2415); Fungal Infection (2419); Abdominal Cramps (2543); Weight Changes (2607)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (fda, reference number: mw5077030) on 18-may-2018.This spontaneous case was reported by a consumer and describes the occurrence of genital haemorrhage ("abnormal bleeding ") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included acetylsalicylic acid (aspirin), clonazepam, cholecalciferol (vitamin d3), cyanocobalamin (vitamin b12), fish oil and rosuvastatin (crestor).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping"), migraine ("migraines"), amenorrhoea ("loss periods"), premature menopause ("early menopause"), fibromyalgia ("fibromyalgia"), back pain ("lower back pain"), hypoaesthesia ("right thigh goes numb"), fungal infection ("yeast infection"), aortic disorder ("aorta infection"), weight increased ("weight gain (b)(6) pounds plus"), tooth disorder ("problem with my teeth") and pelvic pain ("constant pain daily").The patient was treated with surgery (she will have essure removed in 2018).At the time of the report, the genital haemorrhage, abdominal pain lower, migraine, amenorrhoea, premature menopause, fibromyalgia, back pain, hypoaesthesia, fungal infection, aortic disorder, weight increased, tooth disorder and pelvic pain outcome was unknown.The reporter considered abdominal pain lower, amenorrhoea, aortic disorder, back pain, fibromyalgia, fungal infection, genital haemorrhage, hypoaesthesia, migraine, pelvic pain, premature menopause, tooth disorder and weight increased to be related to essure.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

This case was initially received via regulatory authority (fda, reference number: mw5077030) on 18-may-2018.The most recent information was received on 17-sep-2018.This spontaneous case was reported by a consumer and describes the occurrence of genital haemorrhage ("abnormal bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included acetylsalicylic acid (aspirin low), clonazepam, cholecalciferol (vitamin d3), cyanocobalamin (vitamin b12), fish oil and rosuvastatin (crestor).On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), abdominal pain lower ("cramping"), migraine ("migraines"), amenorrhoea ("loss periods"), premature menopause ("early menopause"), fibromyalgia ("fibromyalgia"), back pain ("lower back pain"), hypoaesthesia ("right thigh goes numb"), fungal infection ("yeast infection"), infective aortitis ("aorta infection"), weight increased ("weight gain 50 pounds plus"), tooth disorder ("problem with my teeth") and pelvic pain ("constant pain daily").The patient was treated with surgery (she will have essure removed in 2018).At the time of the report, the genital haemorrhage, abdominal pain lower, migraine, amenorrhoea, premature menopause, fibromyalgia, back pain, hypoaesthesia, fungal infection, infective aortitis, weight increased, tooth disorder and pelvic pain outcome was unknown.The reporter considered abdominal pain lower, amenorrhoea, back pain, fibromyalgia, fungal infection, genital haemorrhage, hypoaesthesia, infective aortitis, migraine, pelvic pain, premature menopause, tooth disorder and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-sep-2018: quality-safety evaluation of ptc.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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: 7531546
• MDR Text Key: 108862278
• Report Number: 2951250-2018-02310
• Device Sequence Number: 1
• Product Code: HHS
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ASPIRIN LOW; CLONAZEPAM; CLONAZEPAM; CRESTOR; CRESTOR; FISH OIL; FISH OIL; VITAMIN B12; VITAMIN B12; VITAMIN D3; VITAMIN D3; ASPIRIN; CLONAZEPAM; CRESTOR; FISH OIL; VITAMIN B12; VITAMIN D3
• Patient Outcome(s): Other; Required Intervention