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 Abdominal Pain (1685); Bruise/Contusion (1754); Fatigue (1849); Headache (1880); Incontinence (1928); Itching Sensation (1943); Nausea (1970); Pain (1994); Swelling (2091); Blurred Vision (2137); Vomiting (2144); Tingling (2171); Dizziness (2194); Arthralgia (2355); Numbness (2415); Palpitations (2467); Confusion/ Disorientation (2553); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666)

Event Date 03/27/2011

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (food and drug administration, reference number: mw5079279) on 04-sep-2018.The most recent information was received on 25-jun-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain / pain / constant pain'), increased tendency to bruise ('bruise easily') and genital haemorrhage ('bleeding / extreme bleeding') in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included gallbladder operation and hernia repair.On (b)(6) 2017 physical exam: gastrointestinal: umbilical mass c/w umbilical hernia superior to umbilical area hernia: umbilical (see above, measure about 5 cm, tender to palpation.Genitourinary: entire pelvis with pain left greater than right with palpation of uterus with manipulation.No guarding or rebound.On (b)(6) 2017- physical exam: genitourinary: bilateral uterosacral nodularity and pain, no masses but adnexal pain with mobility of uterus c/w adhesions.Concurrent conditions included hair loss, retention of urine, latex allergy, nocturia, umbilical hernia and anxiety.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), increased tendency to bruise (seriousness criterion disability), vision blurred ("blurred vision / blurry spots"), bladder dilatation ("my bladder is bigger than my uterus"), headache ("headaches / constant headache"), menorrhagia ("abnormal heavy periods"), the first episode of fatigue ("fatigue"), memory impairment ("forgetfulness"), pain ("my whole body aches everyday"), dysgeusia ("all day metal taste in mouth"), pollakiuria ("constantly i have to pee"), dizziness ("constantly dizzy\dizziness") and the first episode of swelling ("swelling look like am always pregnant"), 1 day after insertion of essure.On an unknown date, the patient experienced urinary tract disorder ("urinary problems"), genital haemorrhage (seriousness criterion medically significant), dyspareunia ("dyspareunia"), the second episode of fatigue ("fatigue"), cystic fibrosis ("cystic fibrosis syndrome"), endometriosis ("endometriosis"), the second episode of swelling ("swelling"), nausea ("nausea all the time"), vomiting ("vomiting every time i eat constant pain"), abdominal distension ("bloating"), migraine ("migraines"), feeling abnormal ("brain fog"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), back disorder ("back problems"), arthropathy ("joint problems"), palpitations ("heart palpitations"), pruritus ("itching all the time"), breast tenderness ("breast tenderness") and abdominal pain ("vomiting every time i eat constant pain") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").The patient was treated with surgery (hysterectomy with bilateral salpingectomy, dilation and curettage).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, increased tendency to bruise, vision blurred, bladder dilatation, headache, menorrhagia, memory impairment, pain, dysgeusia, pollakiuria, dizziness, urinary tract disorder, genital haemorrhage, dyspareunia, the last episode of fatigue, cystic fibrosis, endometriosis, the last episode of swelling, nausea, vomiting, abdominal distension, migraine, feeling abnormal, hypoaesthesia, paraesthesia, back disorder, arthropathy, palpitations, pruritus, weight decreased, breast tenderness, weight increased and abdominal pain outcome was unknown.The reporter provided no causality assessment for bladder dilatation, dizziness, dysgeusia, headache, increased tendency to bruise, memory impairment, menorrhagia, pain, pollakiuria, vision blurred, the first episode of fatigue and the first episode of swelling with essure.The reporter considered abdominal distension, abdominal pain, arthropathy, back disorder, breast tenderness, cystic fibrosis, dyspareunia, endometriosis, feeling abnormal, genital haemorrhage, hypoaesthesia, migraine, nausea, palpitations, paraesthesia, pelvic pain, pruritus, urinary tract disorder, vomiting, weight decreased, weight increased, the second episode of fatigue and the second episode of swelling to be related to essure.The reporter commented: an injury (disability) was mentioned but not specified and /or assigned to one of the events.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on an unknown date: pelvic pain and abnormal bleeding.An injury (disability) was mentioned but not specified and /or assigned to one of the events.Concerning the injuries reported in this case, the following ones were described in patient¿s medical record; confirming: breast tenderness, pelvic pain, low back pain, headaches, menorrhagia, dyspareunia.Most recent follow-up information incorporated above includes: on 25-jun-2019: pfs and mr was received.Reporter information was updated.New events: urinary problems, bleeding, dyspareunia, fatigue, cystic fibrosis syndrome, endometriosis, swelling, nausea all the time, vomiting every time i eat, bloating, migraines, brain fog, numbness, back problems, joint problems, heart palpitations, itching all the time, weight loss, weight gain, breast tenderness, abdominal pain were added.Medical history was added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this 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 07981
• MDR Report Key: 8761753
• MDR Text Key: 150127180
• Report Number: 2951250-2019-03269
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2019

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: 06/25/2019
• Initial Date FDA Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 27 YR