| Model Number ESS205 |
| Device Problems
Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Abdominal Pain (1685); Edema (1820); Fatigue (1849); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Pain (1994); Pelvic Inflammatory Disease (2000); Perforation (2001); Rash (2033); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Arthralgia (2355); Shaking/Tremors (2515); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Genital Bleeding (4507); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of the first episode of device dislocation ("a possible migration of the essure"), device breakage ("essure coil in the left tube broke during extraction of the left tube, the remaining portion was in the uterine cornua , successfully removed") and the second episode of device dislocation ("the left essure coil was pushing at an angle into the tube") in a (b)(6) female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: before essure, plaintiff¿s menstrual periods were not as heavy nor did they last as long and she had no problem with going about her daily life.Concomitant products included medroxyprogesterone acetate (depo-provera) for menstrual cycle management.On (b)(6) 2006, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced pruritus ("itching") and face oedema ("facial edema").On (b)(6) 2007, 1 year 1 month after insertion of essure (ess205), the patient experienced back pain ("low back pain") and pollakiuria ("urinary frequency").On (b)(6) 2008, the patient experienced the first episode of vaginal discharge ("vaginal discharge / homogenous white discharge").On (b)(6) 2010, the patient experienced the second episode of vaginal discharge ("vaginal discharge and odor") and vulvovaginal burning sensation ("burning sensation").In 2013, the patient experienced dysfunctional uterine bleeding ("dysfunctional uterine bleeding / bleeding daily for a month / bleeding").On an unknown date, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criteria medically significant and intervention required), menorrhagia ("menorrhagia / menstrual bleeding continuously"), dysmenorrhoea ("dysmenorrhea"), pelvic pain ("pelvic pain"), rash ("skin rashes"), tremor ("full-body tremors / rapid body shakes"), fatigue ("fatigue"), dysuria ("dysuria"), arthralgia ("knee pain"), dyspareunia ("dyspareunia") and abdominal pain ("lower abdominal pain / epigastric pain").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("essure coil in the left tube broke during extraction of the left tube").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure coils).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, the last episode of device dislocation, complication of device removal, menorrhagia, dysmenorrhoea, pelvic pain, rash, tremor, fatigue, dysuria, arthralgia, dyspareunia, abdominal pain, back pain, pruritus, face oedema, pollakiuria, the last episode of vaginal discharge, vulvovaginal burning sensation and dysfunctional uterine bleeding outcome was unknown.The reporter considered abdominal pain, arthralgia, back pain, complication of device removal, device breakage, dysfunctional uterine bleeding, dysmenorrhoea, dyspareunia, dysuria, face oedema, fatigue, menorrhagia, pelvic pain, pollakiuria, pruritus, rash, tremor, vulvovaginal burning sensation, the first episode of device dislocation, the first episode of vaginal discharge, the second episode of device dislocation and the second episode of vaginal discharge to be related to essure (ess205).The reporter commented: her symptomatology developed gradually in the months and years after the essure implant procedure.Essure coil in the left tube broke during extraction of the left tube, and the remaining portion of the coil was in the uterine cornua.He successfully removed that portion of the coil and further noted that the left essure coil was pushing at an angle into the tube.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) 2007: normal hysterosalpingogram - on (b)(6) 2006: occlusion was viewed in both fallopian tubes.Ultrasound scan - in (b)(6) 2015: a possible migration of the essure coil.On (b)(6) 2008, she underwent pelvic exam yielded a finding of a moderate amount of homogenous white discharge.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.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("essure coil in the left tube broke during extraction of the left tube, the remaining portion was in the uterine cornua , successfully removed"), device dislocation ("a possible migration of the essure/the left essure coil was pushing at an agle into the tube"), genital haemorrhage ("bleeding"), dysfunctional uterine bleeding ("dysfunctional uterine bleeding / bleeding daily for a month / bleeding") and endometritis ("endometritis") in a 38-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: before essure, plaintiff¿s menstrual periods were not as heavy nor did they last as long and she had no problem with going about her daily life.Concomitant products included medroxyprogesterone acetate (depo-provera) for menstrual cycle management as well as iron (iron complex) and medroxyprogesterone acetate (provera).On (b)(6) 2006, the patient had essure (ess205) inserted.On (b)(6) 2006, 3 months 16 days after insertion of essure (ess205), the patient experienced vaginal haemorrhage ("vaginal bleeding").On (b)(6) 2007, the patient experienced rash ("skin rashes"), pruritus ("itching") and face oedema ("facial edema").On (b)(6) 2007, the patient experienced back pain ("low back pain") and pollakiuria ("urinary frequency") with dysuria.On (b)(6) 2008, the patient experienced the first episode of vaginal discharge ("vaginal discharge / homogenous white discharge").On (b)(6) 2010, the patient experienced the second episode of vaginal discharge ("vaginal discharge and odor") and vulvovaginal burning sensation ("burning sensation").In 2013, the patient experienced dysfunctional uterine bleeding (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("essure coil in the left tube broke during extraction of the left tube").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), endometritis (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea"), pelvic pain ("pelvic pain /pelvic cramping"), fatigue ("fatigue"), arthralgia ("knee pain"), dyspareunia ("dyspareunia"), abdominal pain lower ("lower abdominal pain"), abdominal pain upper ("epigastric pain"), hypersensitivity ("allergic reaction"), anaemia ("anemia"), coital bleeding ("post coital bleeding"), vaginal infection ("vaginitis"), bacterial vaginosis ("bacterial vaginosis"), menstruation irregular ("continued irregular periods") and vulvovaginal mycotic infection ("vulvovaginal mycotic infection").On an unknown date, the patient experienced menorrhagia ("menorrhagia / menstrual bleeding continuously /heavy periods").On an unknown date, the patient experienced tremor ("full-body tremors / rapid body shakes").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure coils).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, dysfunctional uterine bleeding, complication of device removal, menorrhagia, dysmenorrhoea, pelvic pain, rash, tremor, fatigue, arthralgia, dyspareunia, back pain, pruritus, face oedema and the last episode of vaginal discharge outcome was unknown and the device dislocation, genital haemorrhage, endometritis, abdominal pain lower, abdominal pain upper, hypersensitivity, pollakiuria, vulvovaginal burning sensation, anaemia, coital bleeding, vaginal haemorrhage, vaginal infection, bacterial vaginosis, menstruation irregular and vulvovaginal mycotic infection had resolved.The reporter considered abdominal pain lower, anaemia, arthralgia, back pain, bacterial vaginosis, coital bleeding, complication of device removal, device breakage, device dislocation, dysfunctional uterine bleeding, dysmenorrhoea, dyspareunia, face oedema, fatigue, menorrhagia, pelvic pain, pollakiuria, pruritus, rash, tremor, vaginal haemorrhage, vaginal infection, vulvovaginal burning sensation, the first episode of vaginal discharge and the second episode of vaginal discharge to be related to essure (ess205).No further causality assessment were provided for the product.The reporter commented: her symptomatology developed gradually in the months and years after the essure implant procedure.Essure coil in the left tube broke during extraction of the left tube, and the remaining portion of the coil was in the uterine cornua.He successfully removed that portion of the coil and further noted that the left essure coil was pushing at an agle into the tube.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) 2007: normal hysterosalpingogram - on (b)(6) 2006: occlusion was viewed in both fallopian tubes.Ultrasound scan - in december 2015: a possible migration of the essure coil.On (b)(6) 2008, she underwent pelvic exam yielded a finding of a moderate amount of homogenous white discharge.Most recent follow-up information incorporated above includes: on 14-jun-2018: summons received: events added: anemia, post coital bleeding, vaginal bleeding, urinary frequency, bacterial vaginosis, vaginitis,abdominal pain lower,endometritis,allergic reaction,continued irregular periods,vulvovaginal mycotic infection,genital bleeding.Updated outcome, onset date.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.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("essure coil in the left tube broke during extraction of the left tube, the remaining portion was in the uterine cornua , successfully removed"), device dislocation ("a possible migration of the essure/the left essure coil was pushing at an agle into the tube"), genital haemorrhage ("bleeding"), dysfunctional uterine bleeding ("dysfunctional uterine bleeding / bleeding daily for a month / bleeding") and endometritis ("endometritis/low-grade endometritis") in a 38-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Medical conditions: before essure, plaintiff¿s menstrual periods were not as heavy nor did they last as long and she had no problem with going about her daily life.Concomitant products included medroxyprogesterone acetate (depo-provera) for menstrual cycle management as well as iron (iron complex) and medroxyprogesterone acetate (provera).On (b)(6) 2006, the patient had essure (ess205) inserted.On (b)(6) 2006, 3 months 16 days after insertion of essure (ess205), the patient experienced vaginal haemorrhage ("vaginal bleeding").On (b)(6) 2007, the patient experienced rash ("skin rashes/allergic reaction"), pruritus ("itching") and face oedema ("facial edema").On (b)(6) 2007, the patient experienced back pain ("low back pain") and pollakiuria ("urinary frequency") with dysuria.On (b)(6) 2008, the patient experienced the first episode of vaginal discharge ("vaginal discharge / homogenous white discharge") with vulvovaginal burning sensation.On (b)(6) 2010, the patient experienced the second episode of vaginal discharge ("vaginal discharge and odor").In 2013, the patient experienced dysfunctional uterine bleeding (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("essure coil in the left tube broke during extraction of the left tube").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), endometritis (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea"), pelvic pain ("pelvic pain /pelvic cramping"), fatigue ("fatigue"), arthralgia ("knee pain"), dyspareunia ("dyspareunia"), abdominal pain lower ("lower abdominal pain"), abdominal pain upper ("epigastric pain"), hypersensitivity ("allergic reaction"), anaemia ("anemia"), coital bleeding ("post coital bleeding"), vaginal infection ("vaginitis"), bacterial vaginosis ("bacterial vaginosis"), menstruation irregular ("continued irregular periods"), vulvovaginal mycotic infection ("vulvovaginal mycotic infection"), vaginal odour ("vaginal odor"), menometrorrhagia ("she has had very heavy periods with increased duration./experienced menstrual bleeding continuously for the previous two weeks.") and genital burning sensation ("external genitalia burning").On an unknown date, the patient experienced menorrhagia ("menorrhagia / menstrual bleeding continuously /heavy periods/passing clots occurring outside of her normal menses").On an unknown date, the patient experienced tremor ("full-body tremors / rapid body shakes").The patient was treated with surgery (removed the remaining portion of the coil) and surgery (laparoscopic bilateral salpingectomy with removal of essure coils).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, dysfunctional uterine bleeding, complication of device removal, menorrhagia, dysmenorrhoea, pelvic pain, rash, tremor, fatigue, arthralgia, dyspareunia, back pain, pruritus, face oedema, the last episode of vaginal discharge, vaginal odour, menometrorrhagia and genital burning sensation outcome was unknown and the device dislocation, genital haemorrhage, endometritis, abdominal pain lower, abdominal pain upper, hypersensitivity, pollakiuria, anaemia, coital bleeding, vaginal haemorrhage, vaginal infection, bacterial vaginosis, menstruation irregular and vulvovaginal mycotic infection had resolved.The reporter considered abdominal pain lower, abdominal pain upper, anaemia, arthralgia, back pain, bacterial vaginosis, coital bleeding, complication of device removal, device breakage, device dislocation, dysfunctional uterine bleeding, dysmenorrhoea, dyspareunia, endometritis, face oedema, fatigue, genital burning sensation, genital haemorrhage, hypersensitivity, menometrorrhagia, menorrhagia, menstruation irregular, pelvic pain, pollakiuria, pruritus, rash, tremor, vaginal haemorrhage, vaginal infection, vaginal odour, vulvovaginal mycotic infection, the first episode of vaginal discharge and the second episode of vaginal discharge to be related to essure (ess205).The reporter commented: her symptomatology developed gradually in the months and years after the essure implant procedure.Essure coil in the left tube broke during extraction of the left tube, and the remaining portion of the coil was in the uterine cornua.He successfully removed that portion of the coil and further noted that the left essure coil was pushing at an agle into the tube.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) 2007: normal hysterosalpingogram - on (b)(6) 2006: occlusion was viewed in both fallopian tubes.Ultrasound scan - in (b)(6) 2015: a possible migration of the essure coil.On (b)(6) 2008, she underwent pelvic exam yielded a finding of a moderate amount of homogenous white discharge.Most recent follow-up information incorporated above includes: on 16-aug-2018: legal complaint received.Event added- vaginal odor,she has had very heavy periods with increased duration./experienced menstrual bleeding continuously for the previous two weeks,external genitalia burning.Event verbatim was upated as menorrhagia / menstrual bleeding continuously /heavy periods/passing clots occurring outside of her normal menses.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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure coil in the left tube broke during extraction of the left tube, the remaining portion was in the uterine cornua , successfully removed'), device dislocation ('a possible migration of the essure/the left essure coil was pushing at an agle into the tube'), genital haemorrhage ('bleeding'), abnormal uterine bleeding ('dysfunctional uterine bleeding / bleeding daily for a month / bleeding') and endometritis ('endometritis/low-grade endometritis') in a 26-year-old female patient who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included sore throat, cough, head fullness, tinnitus and paratubal cyst.Before essure, plaintiff¿s menstrual periods were not as heavy nor did they last as long and she had no problem with going about her daily life.Concomitant products included medroxyprogesterone acetate (depo-provera) for menstrual cycle management as well as iron (iron complex) and medroxyprogesterone acetate (provera).On (b)(6) 2006, the patient had essure (ess205) inserted.On (b)(6) 2006, the patient experienced vaginal haemorrhage ("vaginal bleeding"), 3 months 16 days after insertion of essure (ess205).On (b)(6) 2007, the patient experienced dermatitis allergic ("skin rashes/allergic reaction"), pruritus ("itching") and face oedema ("facial edema").On (b)(6) 2007, the patient experienced back pain ("low back pain") and pollakiuria ("urinary frequency") with dysuria.On (b)(6) 2008, the patient experienced vaginal discharge ("vaginal discharge / homogenous white discharge") with vulvovaginal burning sensation.On (b)(6) 2010, the patient experienced offensive vaginal discharge ("vaginal discharge and odor").In 2013, the patient experienced abnormal uterine bleeding (seriousness criterion medically significant).On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("essure coil in the left tube broke during extraction of the left tube").On an unknown date, the patient experienced tremor ("full-body tremors / rapid body shakes").On an unknown date, the patient experienced the first episode of heavy menstrual bleeding ("menorrhagia / menstrual bleeding continuously /heavy periods/passing clots occurring outside of her normal menses").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), endometritis (seriousness criterion medically significant), dysmenorrhoea ("dysmenorrhea"), pelvic pain ("pelvic pain /pelvic cramping"), fatigue ("fatigue"), arthralgia ("knee pain"), dyspareunia ("dyspareunia"), abdominal pain lower ("lower abdominal pain"), abdominal pain upper ("epigastric pain"), hypersensitivity ("allergic reaction"), anaemia ("anemia"), coital bleeding ("post coital bleeding"), vaginal infection ("vaginitis"), bacterial vaginosis ("bacterial vaginosis"), menstruation irregular ("continued irregular periods"), vulvovaginal mycotic infection ("vulvovaginal mycotic infection"), vaginal odour ("vaginal odor"), the second episode of heavy menstrual bleeding ("she has had very heavy periods with increased duration./experienced menstrual bleeding continuously for the previous two weeks."), genital burning sensation ("external genitalia burning") and ovarian cyst ("left ovarian simple cyst").The patient was treated with surgery (laparoscopic bilateral salpingectomy with removal of essure coils and removed the remaining portion of the coil).Essure (ess205) was removed on (b)(6) 2016.At the time of the report, the device breakage, abnormal uterine bleeding, complication of device removal, dysmenorrhoea, pelvic pain, dermatitis allergic, tremor, fatigue, vaginal discharge, arthralgia, dyspareunia, back pain, pruritus, face oedema, offensive vaginal discharge, vaginal odour, the last episode of heavy menstrual bleeding, genital burning sensation and ovarian cyst outcome was unknown and the device dislocation, genital haemorrhage, endometritis, abdominal pain lower, abdominal pain upper, hypersensitivity, pollakiuria, anaemia, coital bleeding, vaginal haemorrhage, vaginal infection, bacterial vaginosis, menstruation irregular and vulvovaginal mycotic infection had resolved.The reporter considered abdominal pain lower, abdominal pain upper, abnormal uterine bleeding, anaemia, arthralgia, back pain, bacterial vaginosis, coital bleeding, complication of device removal, dermatitis allergic, device breakage, device dislocation, dysmenorrhoea, dyspareunia, endometritis, face oedema, fatigue, genital burning sensation, genital haemorrhage, hypersensitivity, menstruation irregular, ovarian cyst, pelvic pain, pollakiuria, pruritus, tremor, vaginal discharge, vaginal haemorrhage, vaginal infection, vaginal odour, vulvovaginal mycotic infection, the first episode of heavy menstrual bleeding, offensive vaginal discharge and the second episode of heavy menstrual bleeding to be related to essure (ess205).The reporter commented: her symptomatology developed gradually in the months and years after the essure implant procedure.Essure coil in the left tube broke during extraction of the left tube, and the remaining portion of the coil was in the uterine cornua.He successfully removed that portion of the coil and further noted that the left essure coil was pushing at an agle into the tube.Right-4 coils were noted to be protruding into the uterine cavity.Left- 4 coils present in the intrauterine cavity.Diagnostic results (normal ranges are provided in parenthesis if available): haemoglobin - on (b)(6) 2007: results: normal.Hysterosalpingogram - on (b)(6) 2006: results: occlusion was viewed in both fallopian tubes.Ultrasound scan - in (b)(6) 2015: results: a possible migration of the essure coil.Diagnostic results: on (b)(6) 2008, she underwent pelvic exam yielded a finding of a moderate amount of homogenous white discharge.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: device breakage , device dislocation.Most recent follow-up information incorporated above includes: on 15-jun-2021: mr received.Reporter information , date of birth , other relevant history added and rcc was updated.Event left ovarian simple cyst added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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