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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Arthralgia (2355); Depression (2361); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: unknown, right coil missing') and genital haemorrhage ('general abnormal bleeding') in a (b)(6) female patient who had essure (batch no.B94874) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included morbid obesity.In (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), bladder disorder ("bladder/urinary problems-bladder problems/ bladder or urinary problems or changes") and urinary tract disorder ("urinary problems").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2014, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In june 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse}").In (b)(6) 2014, the patient experienced migraine ("migraine/ migraines/headaches"), fatigue ("fatigue"), vision blurred ("vision/eye problems type: blurry vision") and weight fluctuation ("weight gain/ loss (specify which one) weight gain and weight loss, it fluctuates").In (b)(6) 2015, the patient experienced nausea ("nausea").On (b)(6) 2015, the patient experienced bacterial vaginosis ("infection (bladder/urinary tract/vaginal) type: bacterial vaginosis").In august 2015, the patient experienced mood altered ("hormonal changes/ hormonal changes describe: mood changes"), depression ("depression") and vaginal discharge ("vaginal discharge").In (b)(6) 2016, the patient experienced rash ("rash/ rashes or skin conditions type: undiagnosed skin rash").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), skin disorder ("skin condition"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), alopecia ("hair loss"), pelvic pain ("pain") and arthralgia ("left side hip area/ right side hip area pain").Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, dyspareunia, dysmenorrhoea, rash, bladder disorder, mood altered, migraine, nausea, urinary tract disorder, skin disorder, headache, vaginal haemorrhage, menorrhagia, fatigue, alopecia, depression, bacterial vaginosis, pelvic pain, vaginal discharge, vision blurred, weight fluctuation and arthralgia outcome was unknown.The reporter considered alopecia, arthralgia, bacterial vaginosis, bladder disorder, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, mood altered, nausea, pelvic pain, rash, skin disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vision blurred and weight fluctuation to be related to essure.The reporter commented: it was reported that she had trailing coils: left 4, right 4.Essure removal surgery not yet scheduled.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 39.3 kg/sqm.Imaging procedure on (b)(6) 2014: results of confirm.Test: other.Most recent follow-up information incorporated above includes: on 18-oct-2019: reporters, patient demographics, medical history were added.Added lot number.Added events abnormal bleeding (vaginal, menorrhagia), fatigue, hair loss, depression, infection (bladder/urinary tract/vaginal) type: bacterial vaginosis, migration of essure device location of device: unknown, right coil missing, pain, vaginal discharge, vision/eye problems type: blurry vision, weight gain/ loss (specify which one) weight gain and weight loss, it fluctuates, left side hip area/ right side hip area pain.Updated event mood altered.Updated reported term of event migraine, rash.Incident: we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: unknown, right coil missing') and genital haemorrhage ('general abnormal bleeding') in a 21-year-old female patient who had essure (batch no.B94874) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included morbid obesity.On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), bladder disorder ("bladder/urinary problems-bladder problems/ bladder or urinary problems or changes") and urinary tract disorder ("urinary problems").On (b)(6) 2014, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse}").In (b)(6) 2014, the patient experienced migraine ("migraine/ migraines/headaches"), fatigue ("fatigue"), vision blurred ("vision/eye problems type: blurry vision") and weight fluctuation ("weight gain/ loss (specify which one) weight gain and weight loss, it fluctuates").In (b)(6) 2015, the patient experienced nausea ("nausea").On (b)(6) 2015, the patient experienced bacterial vaginosis ("infection (bladder/urinary tract/vaginal) type: bacterial vaginosis").In (b)(6) 2015, the patient experienced mood altered ("hormonal changes/ hormonal changes describe: mood changes"), depression ("depression") and vaginal discharge ("vaginal discharge").In (b)(6) 2016, the patient experienced rash ("rash/ rashes or skin conditions type: undiagnosed skin rash").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), skin disorder ("skin condition"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), alopecia ("hair loss"), pelvic pain ("pain") and arthralgia ("left side hip area/ right side hip area pain").Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, dyspareunia, dysmenorrhoea, rash, bladder disorder, mood altered, migraine, nausea, urinary tract disorder, skin disorder, headache, vaginal haemorrhage, menorrhagia, fatigue, alopecia, depression, bacterial vaginosis, pelvic pain, vaginal discharge, vision blurred, weight fluctuation and arthralgia outcome was unknown.The reporter considered alopecia, arthralgia, bacterial vaginosis, bladder disorder, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, mood altered, nausea, pelvic pain, rash, skin disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vision blurred and weight fluctuation to be related to essure.The reporter commented: it was reported that she had trailing coils: left 4, right 4.Essure removal surgery not yet scheduled.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 39.3 kg/sqm.Imaging procedure - on (b)(6) 2014: results of confirm.Test: other.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of product technical problem.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('migration of essure device location of device: unknown, right coil missing') in a 21-year-old female patient who had essure (batch no.B94874) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included morbid obesity.In (b)(6)2014, the patient experienced genital haemorrhage ("general abnormal bleeding"), bladder disorder ("bladder/urinary problems-bladder problems/ bladder or urinary problems or changes") and urinary tract disorder ("urinary problems").On (b)(6)2014, the patient had essure inserted.On (b)(6)2014, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6)2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse}").In (b)(6)2014, the patient experienced migraine ("migraine/ migraines/headaches"), fatigue ("fatigue"), vision blurred ("vision/eye problems type: blurry vision") and weight fluctuation ("weight gain/ loss (specify which one) weight gain and weight loss, it fluctuates").In (b)(6)2015, the patient experienced nausea ("nausea").On (b)(6)2015, the patient experienced bacterial vaginosis ("infection (bladder/urinary tract/vaginal) type: bacterial vaginosis").In (b)(6)2015, the patient experienced mood altered ("hormonal changes/ hormonal changes describe: mood changes"), depression ("depression") and vaginal discharge ("vaginal discharge").In (b)(6)2016, the patient experienced rash ("rash/ rashes or skin conditions type: undiagnosed skin rash").On an unknown date, the patient experienced device dislocation (seriousness criterion medically significant), skin disorder ("skin condition"), headache ("headaches"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), alopecia ("hair loss"), the first episode of pelvic pain ("pain"), arthralgia ("left side hip area/ right side hip area pain") and the second episode of pelvic pain ("stabbing pain").Essure treatment was not changed.At the time of the report, the device dislocation, genital haemorrhage, dyspareunia, dysmenorrhoea, rash, bladder disorder, mood altered, migraine, nausea, urinary tract disorder, skin disorder, headache, vaginal haemorrhage, menorrhagia, fatigue, alopecia, depression, bacterial vaginosis, vaginal discharge, vision blurred, weight fluctuation, arthralgia and the last episode of pelvic pain outcome was unknown.The reporter considered alopecia, arthralgia, bacterial vaginosis, bladder disorder, depression, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, mood altered, nausea, rash, skin disorder, urinary tract disorder, vaginal discharge, vaginal haemorrhage, vision blurred, weight fluctuation, the first episode of pelvic pain and the second episode of pelvic pain to be related to essure.The reporter commented: it was reported that she had trailing coils: left 4, right 4.Essure removal surgery not yet scheduled.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 39.3 kg/sqm.Imaging procedure - on (b)(6)2014: results of confirm.Test: other.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media : reporter added.Event pelvic pain added.A technical investigation will be conducted, including a batch review, and a review of complaint records and other relevant 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
• MDR Report Key: 9283496
• MDR Text Key: 176932211
• Report Number: 2951250-2019-11196
• 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,Followup
• Report Date: 04/17/2020

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 Expiration Date: 11/30/2016
• Device Model Number: ESS305
• Device Lot Number: B94874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 11/08/2019; 11/08/2019
• Supplement Dates FDA Received: 11/11/2019; 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 114