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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Anemia (1706); Diarrhea (1811); Headache (1880); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Blurred Vision (2137); Burning Sensation (2146); Anxiety (2328); Complaint, Ill-Defined (2331); Numbness (2415); Tooth Fracture (2428); Confusion/ Disorientation (2553); Weight Changes (2607); Foreign Body In Patient (2687); Constipation (3274)

Event Type  Injury  

Event Description

This case was initially received via regulatory authority fda (reference number: mw5073910) on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of essure micro-insert migration (the essure device on the right side has migrated outside of the uterus), essure micro-insert dislocation (left side essure is trying to moveout at the present moment), anemia (anemia) and genital bleeding (bleeding) in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant medication: clobetasol ¿ used for symptoms of irritation when she has her period, losartan, multivitamins, vitamin d supplement, armour thyroid.On (b)(6) 2014 she had essure inserted.After implantation she started having pains on her right side.She was diagnosed with right side heavy fecal load, because she goes through spells of constipation even on stool softeners.In 2017 she was diagnosed with non-alcoholic fatty liver disease.She suffers daily with headaches, pains around her rib cage, hip pain, irritable bowel syndrome, spells of constipation or diarrhea, bladder leakage at times, weight loss followed by serious weight gain, anemia- blood transfusion (seriousness criterion medically significant), teeth cracking, itching and rashes, numbness in arm, arms hurt and she gets a knot near the elbows on the outer arm, she swells, has bleeding at time (seriousness criterion medically significant), very painful and what comes out of her burn the outer skin of her vagina, painful intercourse, spells of perpetual periods, swollen liver and spleen, uncontrollable blood pressure even o medication, brain fog, vision blur, pain all over her body including her uterus ¿ it feels like labor all the time, gluten intolerant, feels sick to her stomach every day, legs hurt with pains that extend into her feet, vitamin d, iron and vitamin b12 deficiency, extreme anxiety, neck pain, low back pain, essure device on her right side has migrated outside of the uterus (seriousness criterion hospitalization), the left side is trying to move at the present moment (seriousness criterion medically significant).She is getting a total hysterectomy in 2017.The reporter considered the events 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

He was initially received via regulatory authority (fda, reference number: mw5073910) on (b)(6) 2018.The most recent information was received on (b)(6) 2018.This spontaneous case was reported by a consumer and describes the occurrence of the first episode of device dislocation ("the essure device on the right side has migrated outside of the uterus"), the second episode of device dislocation ("left side essure is trying to moveout at the present moment"), anaemia ("anemia") and genital haemorrhage ("bleeding") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included thyroid (armour thyroid).On (b)(6) 2014, the patient had essure inserted.In 2017, the patient experienced non-alcoholic fatty liver ("nafld - non-alcoholic fatty liver disease") and gluten sensitivity ("gluten intolerant").On an unknown date, the patient experienced the first episode of device dislocation (seriousness criterion hospitalization), the second episode of device dislocation (seriousness criterion medically significant), anaemia (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("pain in right side"), faecaloma ("right side heavy fecal load"), constipation ("spells of constipation"), headache ("headaches"), musculoskeletal chest pain ("pain around rib cage"), arthralgia ("hip pain"), irritable bowel syndrome ("ibs - irritable bowel syndrome"), diarrhoea ("diarrhea"), urinary incontinence ("bladder leakage"), weight fluctuation ("weight loss followed by a serious weight gain"), tooth fracture ("teeth cracking"), pruritus ("itching"), rash ("rashes"), hypoaesthesia ("numbness in arms"), the first episode of pain in extremity ("arms hurt / it hurts to move arms"), limb mass ("knot near the elbows on the outer arm"), swelling ("swell"), dysmenorrhoea ("painful bleeding"), vulvovaginal burning sensation ("what comes out burns the outer skin of vagina"), dyspareunia ("painful intercourse"), menorrhagia ("perpetual period"), hepatomegaly ("swollen liver"), splenomegaly ("swollen splin"), blood pressure inadequately controlled ("uncontrollable blood pressure"), feeling abnormal ("brain fog"), vision blurred ("vision blurs"), pain ("pain all over the body"), uterine pain ("pain including uterus / feels like in labor all the time"), nausea ("sick to stomach every day"), the second episode of pain in extremity ("leg hurts with pains that extend to feet"), vitamin d deficiency ("vitamin d deficiency"), iron deficiency ("iron deficiency"), vitamin b12 deficiency ("vitamin b12 deficiency"), anxiety ("extreme anxiety"), neck pain ("neck pain"), back pain ("low back pain") and irritability ("irritation when on period").The patient was treated with docusate sodium (stool softener), clobetasol, losartan, multivitamin, cholecalciferol (vitamin d) and surgery (total hysterectomy scheduled).Essure treatment was not changed.At the time of the report, the last episode of device dislocation, anaemia, genital haemorrhage, abdominal pain, faecaloma, constipation, non-alcoholic fatty liver, headache, musculoskeletal chest pain, arthralgia, irritable bowel syndrome, diarrhoea, urinary incontinence, weight fluctuation, tooth fracture, pruritus, rash, hypoaesthesia, limb mass, swelling, dysmenorrhoea, vulvovaginal burning sensation, dyspareunia, menorrhagia, hepatomegaly, splenomegaly, blood pressure inadequately controlled, feeling abnormal, vision blurred, pain, uterine pain, gluten sensitivity, nausea, the last episode of pain in extremity, vitamin d deficiency, iron deficiency, vitamin b12 deficiency, anxiety, neck pain, back pain and irritability outcome was unknown.The reporter considered abdominal pain, anaemia, anxiety, arthralgia, back pain, blood pressure inadequately controlled, constipation, diarrhoea, dysmenorrhoea, dyspareunia, faecaloma, feeling abnormal, genital haemorrhage, gluten sensitivity, headache, hepatomegaly, hypoaesthesia, iron deficiency, irritability, irritable bowel syndrome, limb mass, menorrhagia, musculoskeletal chest pain, nausea, neck pain, non-alcoholic fatty liver, pain, pruritus, rash, splenomegaly, swelling, tooth fracture, urinary incontinence, uterine pain, vision blurred, vitamin b12 deficiency, vitamin d deficiency, vulvovaginal burning sensation, weight fluctuation, the first episode of device dislocation, the first episode of pain in extremity, the second episode of device dislocation and the second episode of pain in extremity to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of product technical complaints.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: 7178191
• MDR Text Key: 96858668
• Report Number: 2951250-2018-00286
• 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: 09/05/2018

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID; ARMOUR THYROID; ARMOUR THYROID
• Patient Outcome(s): Hospitalization; Other