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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
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BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE Back to Search Results
Model Number ESS305
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Fatigue (1849); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Abnormal Vaginal Discharge (2123); Tingling (2171); Numbness (2415); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687)
Event Date 07/24/2018
Event Type  Injury  
Event Description
This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('migration of essure device location of device: right coil migrated towards uterus') 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 allergic rhinitis, kidney stones, bacterial vaginosis, dysuria, uterine bleeding and dysfunctional uterine bleeding.Concomitant products included ibuprofen.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse) / painful cramping"), 3 months 29 days after insertion of essure.On (b)(6)2013, the patient experienced vaginal discharge ("vaginal discharge") and vaginal odour ("vaginal odor").On (b)(6) 2013, the patient experienced pelvic pain ("pain/ pelvic pain/pain in side") and abdominal pain ("pain/right abdomen").On (b)(6) 2014, the patient experienced eye movement disorder ("vision/eye problems type: eye twitching").On (b)(6) 2014, the patient experienced fatigue ("fatigue").On (b)(6) 2014, the patient was found to have weight increased ("weight gain") and experienced disturbance in attention ("decreased concentration").On (b)(6) 2016, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia) / heavier than normal.Duration extended from a normal 2-3 dats to 10 days / heavy bleeding / large clotting") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2018, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced feeling abnormal ("brain fog"), hypoaesthesia ("numbness in hands and feet"), urticaria ("random hives"), mood swings ("mood swings") and pruritus ("itching").The patient was treated with surgery (underwent hysterectomy (full),salpingectomy(bilateral removal of fallopian tubes) on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, pelvic pain, menorrhagia, vaginal haemorrhage, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, feeling abnormal, disturbance in attention, urticaria, mood swings, vaginal odour and pruritus outcome was unknown, the abdominal pain, eye movement disorder and hypoaesthesia had resolved and the fatigue was resolving.The reporter considered abdominal pain, device expulsion, disturbance in attention, dysmenorrhoea, dyspareunia, eye movement disorder, fatigue, feeling abnormal, hypoaesthesia, menorrhagia, mood swings, pelvic pain, pruritus, urticaria, vaginal discharge, vaginal haemorrhage, vaginal odour and weight increased to be related to essure.The reporter commented: the coil deployed with 4 trailing coils on the left.The coil deployed with 1 trailing coils on the right.Current weight (b)(6).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - on (b)(6) 2013: the tubes were closed.Pregnancy test urine - on (b)(6) 2013: negative.Ultrasound pelvis - on (b)(6) 2018: migration of the essure coil in right fallopian tube.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: eye movement disorder, hypoaesthesia, brain fog, hives, pelvic pain, dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs and mr received.Previously reported event "injury" updated to "abnormal bleeding (vaginal)", events- " menorrhagia, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, migration of essure device location of device: right coil migrated towards uterus, pelvic pain, right abdomen pain, vaginal discharge, vision/eye problems type: eye twitching, weight gain, other injury(ies) or complication please describe: brain fog, decreased concentration, numbness in hands and feet, random hives, mood swings,vaginal odor, itching", reporter, medical history, lab data added.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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('migration of essure device location of device: right coil migrated towards uterus') in a 29-year-old 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 allergic rhinitis, kidney stones, bacterial vaginosis, dysuria, uterine bleeding and dysfunctional uterine bleeding.Concomitant products included ibuprofen.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse) / painful cramping"), 3 months 29 days after insertion of essure.On (b)(6) 2013, the patient experienced vaginal discharge ("vaginal discharge") and vaginal odour ("vaginal odor").On (b)(6) 2013, the patient experienced pelvic pain ("pain/ pelvic pain/pain in side") and abdominal pain ("pain/right abdomen").On (b)(6) 2014, the patient experienced eye movement disorder ("vision/eye problems type: eye twitching").On (b)(6) 2014, the patient experienced fatigue ("fatigue").On (b)(6) 2014, the patient was found to have weight increased ("weight gain/ my belly never looked this big either time i was pregnant/ since i have gained 40+ pounds") and experienced disturbance in attention ("decreased concentration").On (b)(6) 2016, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia)/heavier than normal.Duration extended from a normal 2-3 days to 10 days / heavy bleeding / large clotting/heavy bleeding and clotting") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2018, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced feeling abnormal ("brain fog/ the brain fog"), hypoesthesia of gloves-socks type ("numbness in hands and feet"), urticaria ("random hives"), mood swings ("mood swings"), pruritus ("itching"), infection ("infection"), psychological trauma ("psych injury"), polymenorrhoea ("cycle every three weeks"), dry mouth ("very dry mouth"), abdominal distension ("the bloat"), scratch ("scab- type scratch"), blepharospasm ("twitchy eye"), hypoaesthesia ("numbness in my hand and feet"), tenderness ("tenderness") and post procedural discomfort ("discomfort/ uncomfortable after post op").The patient was treated with surgery (underwent hysterectomy (full),salpingectomy(bilateral removal of fallopian tubes) on (b)(6) 2018).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, pelvic pain, menorrhagia, vaginal haemorrhage, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, disturbance in attention, urticaria, mood swings, vaginal odour, pruritus, infection, psychological trauma, polymenorrhoea, dry mouth, tenderness and post procedural discomfort outcome was unknown, the abdominal pain, eye movement disorder and hypoesthesia of gloves-socks type had resolved and the fatigue, feeling abnormal, abdominal distension, scratch, blepharospasm and hypoaesthesia was resolving.The reporter considered abdominal distension, abdominal pain, blepharospasm, device expulsion, disturbance in attention, dry mouth, dysmenorrhoea, dyspareunia, eye movement disorder, fatigue, feeling abnormal, hypoesthesia of gloves-socks type, infection, menorrhagia, mood swings, pelvic pain, polymenorrhoea, post procedural discomfort, pruritus, psychological trauma, scratch, tenderness, urticaria, vaginal discharge, vaginal haemorrhage, vaginal odour, weight increased and hypoaesthesia to be related to essure.The reporter commented: the coil deployed with 4 trailing coils on the left.The coil deployed with 1 trailing coils on the right.Current weight 180 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: the tubes were closed.Pregnancy test urine - on (b)(6) 2013: negative.Ultrasound pelvis - on (b)(6) 2018: migration of the essure coil in right fallopian tube.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: eye movement disorder, hypoaesthesia, brain fog, hives, pelvic pain, dyspareunia".Concerning the injuries reported in this case, the following one/ones was/were reported via social media report : dry mouth, scratch, abdominal distension, blepharospasm, hypoaesthesia, stress, discomfort, frustration tolerance decreased.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-nov-2019: social media received.Reporter information updated.Outcome of event the brain fog was changed from ¿unknown¿ to ¿recovering/resolving¿.Events: very dry mouth, the bloat, scab- type scratch, twitchy eye, numbness in my hand and feet, tenderness, discomfort were newly added.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.
 
Manufacturer Narrative
This spontaneous case was reported by a lawyer and describes the occurrence of device expulsion ('migration of essure device location of device: right coil migrated towards uterus') in a 29-year-old 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 allergic rhinitis, kidney stones, bacterial vaginosis, dysuria, uterine bleeding and dysfunctional uterine bleeding.Concomitant products included ibuprofen.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse) / painful cramping"), 3 months 29 days after insertion of essure.On (b)(6) 2013, the patient experienced vaginal discharge ("vaginal discharge") and vaginal odour ("vaginal odor").On (b)(6) 2013, the patient experienced pelvic pain ("pain/ pelvic pain/pain in side") and abdominal pain ("pain/right abdomen").On (b)(6) 2014, the patient experienced eye movement disorder ("vision/eye problems type: eye twitching").On (b)(6) 2014, the patient experienced fatigue ("fatigue").On (b)(6) 2014, the patient was found to have weight increased ("weight gain") and experienced disturbance in attention ("decreased concentration").On (b)(6) 2016, the patient experienced menorrhagia ("abnormal bleeding (menorrhagia)/heavier than normal.Duration extended from a normal 2-3 days to 10 days / heavy bleeding / large clotting/heavy bleeding and clotting") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On (b)(6) 2016, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2018, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced feeling abnormal ("brain fog"), hypoaesthesia ("numbness in hands and feet"), urticaria ("random hives"), mood swings ("mood swings"), pruritus ("itching"), infection ("infection"), psychological trauma ("psych injury") and polymenorrhoea ("cycle every three weeks").The patient was treated with surgery (underwent hysterectomy (full),salpingectomy(bilateral removal of fallopian tubes) on (b)(6) 2018 ).Essure was removed on (b)(6) 2018.At the time of the report, the device expulsion, pelvic pain, menorrhagia, vaginal haemorrhage, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, feeling abnormal, disturbance in attention, urticaria, mood swings, vaginal odour, pruritus, infection, psychological trauma and polymenorrhoea outcome was unknown, the abdominal pain, eye movement disorder and hypoaesthesia had resolved and the fatigue was resolving.The reporter considered abdominal pain, device expulsion, disturbance in attention, dysmenorrhoea, dyspareunia, eye movement disorder, fatigue, feeling abnormal, hypoaesthesia, infection, menorrhagia, mood swings, pelvic pain, polymenorrhoea, pruritus, psychological trauma, urticaria, vaginal discharge, vaginal haemorrhage, vaginal odour and weight increased to be related to essure.The reporter commented: the coil deployed with 4 trailing coils on the left.The coil deployed with 1 trailing coils on the right.Current weight 180 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 23.3 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: the tubes were closed.Pregnancy test urine - on (b)(6) 2013: negative.Ultrasound pelvis - on (b)(6) 2018 : migration of the essure coil in right fallopian tube.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: eye movement disorder, hypoaesthesia, brain fog, hives, pelvic pain, dyspareunia".Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-nov-2019: plaintiff fact sheet received.Events¿ infection, psych injury and cycle every three weeks" were added.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.
 
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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 Key9305367
MDR Text Key184065295
Report Number2951250-2019-11386
Device Sequence Number1
Product Code HHS
UDI-Device Identifier10888853003051
UDI-Public(01)10888853003051
Combination Product (y/n)N
PMA/PMN Number
P020014
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Type of Report Initial,Followup,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberESS305
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
IBUPROFEN; IBUPROFEN; IBUPROFEN
Patient Outcome(s) Other; Required Intervention;
Patient Age29 YR
Patient Weight65
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