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); Anemia (1706); Cyst(s) (1800); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); Rash (2033); Urinary Tract Infection (2120); Uterine Perforation (2121); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterine perforation'), fallopian tube perforation ('fallopian tube perforation') and genital haemorrhage ('gen.Abnormal bleeding') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergoes essure confirmation test".On (b)(6) 2007, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criterion medically significant), fallopian tube perforation (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("metrorrhagia (bleeding b/w periods)"), iron deficiency anaemia ("anemia"), genital haemorrhage (seriousness criterion medically significant), dermatitis allergic ("allergy: rash/skin condition"), hypersensitivity ("hypersensitivity"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary tract problem"), cystitis ("bladder infection"), urinary tract infection ("urinary tract infection"), vaginal infection ("vaginal infection"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions,"), headache ("headache"), nausea ("nausea"), nervous system disorder ("neuro condit/prob") and psychological trauma ("psych injury ") and was found to have hormone level abnormal ("hormonal changes") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the uterine perforation, fallopian tube perforation, dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, iron deficiency anaemia, genital haemorrhage, dermatitis allergic, hypersensitivity, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, gastrointestinal disorder, hormone level abnormal, headache, nausea, nervous system disorder and weight decreased outcome was unknown.The reporter considered abdominal pain, back pain, bladder disorder, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hypersensitivity, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, nervous system disorder, pelvic pain, psychological trauma, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal infection and weight decreased to be related to essure.The reporter commented: patient received treatment for- dysmenorrhea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, anemia, gen.Abnormal bleed, rash/skin condition, hypersensitivity, psych injury, bladder problem,urinary problem,bladder infection, uti, vaginal infection and vaginal discharge essure insertion date provided in pfs (b)(6) 2007.Quality-safety evaluation of ptc: unable to confirm complaint approximately.Most recent follow-up information incorporated above includes: on 12-sep-2019: pfs received- previously reported event "injury to herself" updated to "fallopian tube perforation", events- "uterine perforation, dysmenorrhea(cramping), dyspareunia(painful sexual intercourse), pelvic pain, abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), metrorrhagia (bleeding b/w periods), anemia, gen.Abnormal.Bleeding, allergic rash, hypersensitivity, psych injury, bladder problem , urinary tract problem, bladder infection, urinary tract infection, vaginal infection, fatigue,, gi conditions, hormonal changes, headaches, nausea, neuro conduit/prob, weight loss and she did not undergoes essure confirmation test", patient demography, lab data 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterine perforation'), fallopian tube perforation ('fallopian tube perforation') and genital haemorrhage ('gen.Abnoramal bleeding') in a 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 unspecified anemia.Concurrent conditions included tooth disorder, acne, migraine and dizziness.Concomitant products included medroxyprogesterone acetate (depo provera).In 2007, the patient experienced menorrhagia ("menorrhagia (heavy menstrual bleeding)") and vaginal haemorrhage ("abnormal bleeding (vaginal)").In december 2007, the patient had essure inserted.In 2008, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), vulvovaginal dryness ("hormonal changes describe: vaginal dryness"), libido decreased ("low libido") and vulvovaginal rash ("allergic or hypersensitivity reaction: type: vaginal area outbreaks").In 2009, the patient experienced pelvic pain ("pelvic pain") and abdominal pain ("abdominal pain").In december 2018, the patient experienced ovarian cyst ("reproductive system disorder or condition type of disorder or condition: ovarian cysts").On an unknown date, the patient experienced uterine perforation (seriousness criterion medically significant), fallopian tube perforation (seriousness criterion medically significant), back pain ("back pain"), metrorrhagia ("metrorrhagia(bleeding b/w periods)"), iron deficiency anaemia ("anemia"), genital haemorrhage (seriousness criterion medically significant), dermatitis allergic ("allergy: rash/skin condition"), hypersensitivity ("hypersensitivity"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary tract problem"), cystitis ("bladder infection"), urinary tract infection ("urinary tract infection"), vaginal infection ("vaginal infection"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions,"), headache ("headache"), nausea ("nausea"), nervous system disorder ("nuero condit/prob") and psychological trauma ("psych injury") and was found to have hormone level abnormal ("hormonal changes") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the uterine perforation, fallopian tube perforation, dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, iron deficiency anaemia, genital haemorrhage, dermatitis allergic, hypersensitivity, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, gastrointestinal disorder, hormone level abnormal, headache, nausea, nervous system disorder, weight decreased, vulvovaginal dryness, libido decreased, ovarian cyst, vulvovaginal rash and vaginal haemorrhage outcome was unknown.The reporter considered abdominal pain, back pain, bladder disorder, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hypersensitivity, iron deficiency anaemia, libido decreased, menorrhagia, metrorrhagia, nausea, nervous system disorder, ovarian cyst, pelvic pain, psychological trauma, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal dryness, vulvovaginal rash and weight decreased to be related to essure.The reporter commented: patient received treatment for- dysmenorrhea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, anemia, gen.Abnormal bleed, rash/skin condition, hypersensitivity, psych injury, bladder problem,urinary problem,bladder infection, uti, vaginal infection and vaginal discharge discrepancy noted: essure insertion date provided in pfs (b)(6) 20007, dec-2007, (b)(6) 2009 currently planning for essure removal: yes.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in march 2008: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2019: pfs and mr received: new events - hormonal changes describe: vaginal dryness & low libido, allergic or hypersensitivity reaction: type: vaginal area outbreaks, reproductive system disorder or condition type of disorder or condition: ovarian cysts, abnormal bleeding(vaginal) were added.Reporter's information, patient demography, lab data, medical history, concomitant condition, concomitant drugs were 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ('uterine perforation'), fallopian tube perforation ('fallopian tube perforation') and genital haemorrhage ('gen.Abnoramal bleeding') in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergoes essure confirmation test".On (b)(6) 2007, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criterion medically significant), fallopian tube perforation (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia(painful sexual intercourse)"), pelvic pain ("pelvic pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), metrorrhagia ("metrorrhagia(bleeding b/w periods)"), iron deficiency anaemia ("anemia"), genital haemorrhage (seriousness criterion medically significant), dermatitis allergic ("allergy: rash/skin condition"), hypersensitivity ("hypersensitivity"), bladder disorder ("bladder problem"), urinary tract disorder ("urinary tract problem"), cystitis ("bladder infection"), urinary tract infection ("urinary tract infection"), vaginal infection ("vaginal infection"), vaginal discharge ("vaginal discharge"), fatigue ("fatigue"), gastrointestinal disorder ("gi conditions,"), headache ("headache"), nausea ("nausea"), nervous system disorder ("nuero condit/prob") and psychological trauma ("psych injury ") and was found to have hormone level abnormal ("hormonal changes") and weight decreased ("weight loss").Essure treatment was not changed.At the time of the report, the uterine perforation, fallopian tube perforation, dysmenorrhoea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, iron deficiency anaemia, genital haemorrhage, dermatitis allergic, hypersensitivity, bladder disorder, urinary tract disorder, cystitis, urinary tract infection, vaginal infection, vaginal discharge, fatigue, gastrointestinal disorder, hormone level abnormal, headache, nausea, nervous system disorder and weight decreased outcome was unknown.The reporter considered abdominal pain, back pain, bladder disorder, cystitis, dermatitis allergic, dysmenorrhoea, dyspareunia, fallopian tube perforation, fatigue, gastrointestinal disorder, genital haemorrhage, headache, hormone level abnormal, hypersensitivity, iron deficiency anaemia, menorrhagia, metrorrhagia, nausea, nervous system disorder, pelvic pain, psychological trauma, urinary tract disorder, urinary tract infection, uterine perforation, vaginal discharge, vaginal infection and weight decreased to be related to essure.The reporter commented: patient received treatment for- dysmenorrhea, dyspareunia, pelvic pain, abdominal pain, back pain, menorrhagia, metrorrhagia, anemia, gen.Abnormal bleed, rash/skin condition, hypersensitivity, psych injury, bladder problem,urinary problem,bladder infection, uti, vaginal infection and vaginal discharge essure insertion date provided in pfs (b)(6) 2007.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: significant update ppc added.No new follow-up information was received from the reporter.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
• MDR Report Key: 9150577
• MDR Text Key: 166776138
• Report Number: 2951250-2019-09375
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA
• Patient Outcome(s): Other