| Model Number ESS305 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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| Patient Problems
Arthritis (1723); Autoimmune Disorder (1732); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Nausea (1970); Pain (1994); Rash (2033); Swelling (2091); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Tingling (2171); Anxiety (2328); Arthralgia (2355); Numbness (2415); Fungal Infection (2419); Neck Pain (2433); Abdominal Cramps (2543); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)
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| Event Date 12/01/2008 |
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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 pelvic pain ("pain") and autoimmune disorder ("autoimmune disorder") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Concomitant products included alprazolam (xanax) since 2013, levothyroxine from 2015 to 2017, oxybutynin (ditropan) since 2015 and sertraline (zoloft) from 2009 to 2012.In 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dyspareunia ("dyspareunia (painful sexual intercourse)").In september 2008, the patient had essure inserted.In 2009, the patient experienced anxiety ("increased anxiety") and mood altered ("moodiness, particularly during menstrual cycle").In 2011, the patient experienced bladder disorder ("bladder problem or changes"), fatigue ("fatigue"), alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), fungal infection ("recurrent yeast infection"), nausea ("nausea") and rash ("rashes / rashes over entire trunk of body").In september 2014, the patient experienced osteoarthritis ("degenerative arthritis").In 2015, the patient experienced hypothyroidism ("hypothyroidism").In (b)(6) 2015, the patient experienced lipoma of breast ("lipoma breast").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), allergy to metals ("allergic or hypersensitivity reaction / reaction to metal"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), urinary tract disorder ("urinary problems or changes"), tooth disorder ("dental problems"), dysmenorrhoea ("dysmenorrhea (cramping)"), constipation ("constipation"), diarrhoea ("diarrhea"), migraine ("migraines"), headache ("headaches"), food allergy ("reactions to wheat"), allergic reaction to excipient ("reaction to dyes"), vaginal discharge ("vaginal discharge"), asthenopia ("eye strain"), vision blurred ("eye blurriness"), weight increased ("weight gain"), uterine pain ("uterus pain"), back pain ("lower back pain"), arthralgia ("hip pain"), hypoaesthesia ("numbness in her leg / numbness in her arms"), neck pain ("neck pain"), musculoskeletal pain ("shoulder pain"), paraesthesia ("tingling in her arms and hands"), premenstrual syndrome ("pms symptoms"), abdominal distension ("bloating"), swelling ("swelling") and fallopian tube spasm ("spasms in one of my fallopian tubes").The patient was treated with surgery (hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, bladder disorder, dysmenorrhoea, dyspareunia, premenstrual syndrome, abdominal distension and swelling had resolved, the autoimmune disorder, allergy to metals, female sexual dysfunction, urinary tract disorder, tooth disorder, fatigue, constipation, diarrhoea, alopecia, anxiety, mood altered, urinary tract infection, fungal infection, migraine, headache, nausea, rash, food allergy, allergic reaction to excipient, lipoma of breast, vaginal discharge, asthenopia, vision blurred, hypothyroidism, weight increased, uterine pain, back pain, arthralgia, hypoaesthesia, neck pain, musculoskeletal pain, paraesthesia and fallopian tube spasm outcome was unknown and the osteoarthritis was resolving.The reporter considered abdominal distension, allergic reaction to excipient, allergy to metals, alopecia, anxiety, arthralgia, asthenopia, autoimmune disorder, back pain, bladder disorder, constipation, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube spasm, fatigue, female sexual dysfunction, food allergy, fungal infection, headache, hypoaesthesia, hypothyroidism, lipoma of breast, menorrhagia, migraine, mood altered, musculoskeletal pain, nausea, neck pain, osteoarthritis, paraesthesia, pelvic pain, premenstrual syndrome, rash, swelling, tooth disorder, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, vision blurred and weight increased to be related to essure.Diagnostic results: on unknown date hysterosalpingogram test showed, first test showed fallopian tubes were not closed off, second test showed they were.Most recent follow-up information incorporated above includes: on 27-feb-2018: pfs received - case updated as incident.New event "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), apareunia (inability to have sexual intercourse), autoimmune disorder, bladder problem or changes, urinary problems or changes, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, constipation, increased anxiety, hair loss, diarrhea, moodiness, urinary tract infection, recurrent yeast infection, migraines, headaches, nausea, pain, rashes, reactions to wheat, reaction to dyes, allergic or hypersensitivity reaction / reaction to metal, lipoma breast, vaginal discharge, eye strain, eye blurriness, degenerative arthritis, hypothyroidism, weight gain, lower back pain, hip pain, numbness in her leg, neck pain, shoulder pain, numbness in her arms, tingling in her arms and hands, pms symptoms, bloating, swelling, spasms in one of my fallopian tubes" were added.Event 'severe injuries' was deleted.Product explant date were added.On 27-feb-2018: fu 1 and fu 2 proceed together.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 pelvic pain ("pain / pain severe and persistent pain"), autoimmune disorder ("autoimmune disorder") and genital haemorrhage ("heavy bleeding") in an adult female patient who had essure (batch no.627735-left, 627296-right) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included tonsillitis, tonsillectomy, flank pain and adenomyosis.On unknown date hysterosalpingogram test showed, first test showed fallopian tubes were not closed off, second test showed they were.On (b)(6) 2017, positive depression screening.On a scale of 1 to 10, the patient rates the pain (pelvic pain) as 6.Previously administered products included for birth control: depo-provera from july 2006 to june 2007; for an unreported indication: antibiotics.Concurrent conditions included depression, unspecified vitamin deficiency, rectal pressure severe, uterine bleeding, adenomyosis, overweight, kidney infection, menstruation irregular, amenorrhoea, urinary frequency, anorexia, stiffness, dizziness, contact dermatitis, palpitations, dysuria, suprapubic pain, acute bronchitis, acute maxillary sinusitis, spondylosis, radiculopathy, vitamin b12 deficiency, urinary urgency, cold intolerance, decreased appetite, hypohidrosis, memory impaired, myalgia, shortness of breath, motor vehicle accident, neurogenic bladder, nocturia, uterine bleeding and tiredness.Concomitant products included alprazolam (xanax) since 2013, calamine;phenol (calamine lotion phenolated), diphenhydramine hydrochloride (benadryl), hydrocortisone, levothyroxine from 2015 to 2017, oxybutynin hydrochloride (ditropan) since 2015 and sertraline hydrochloride (zoloft) from 2009 to 2012.In 2008, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), migraine ("migraines") and headache ("headaches").On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2009, the patient experienced fatigue ("fatigue"), constipation ("constipation / gastrointestinal or digestive system condition - type: constipation"), diarrhoea ("diarrhea / gastrointestinal or digestive system condition - type: diarrhea"), anxiety ("increased anxiety / psychological or psychiatric problems - condition: anxiety") and mood altered ("moodiness, particularly during menstrual cycle").In 2010, the patient experienced allergy to metals ("allergic or hypersensitivity reaction / reaction to metal/ became allergic/sensitive to metals"), bladder disorder ("bladder problem or changes / bladder issues"), urinary tract disorder ("urinary problems or changes"), rash ("rashes / rashes over entire trunk of body"), food allergy ("reactions to wheat/ became allergic/sensitive to wheat") and allergic reaction to excipient ("reaction to dyes/ became allergic/sensitive to dyes").In september 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), vulvovaginal mycotic infection ("recurrent yeast infection") and nausea ("nausea").In 2012, the patient experienced asthenopia ("eye strain / vision/eye problems - type: eye strain") and vision blurred ("eye blurriness / vision/eye problems - type: blurriness").In 2013, the patient experienced tooth disorder ("dental problems") and was found to have weight increased ("weight gain/ weight gain / loss (specify which one) gain").In (b)(6) 2014, the patient experienced osteoarthritis ("degenerative arthritis / autoimmune disorder - type of disorder: degenerative arthritis") and hypothyroidism ("hypothyroidism / autoimmune disorder - type of disorder: hypothyroidism").In december 2015, the patient was found to have lipoma of breast ("lipoma breast / tumor / teratoma / cancer - type: lipoma, breast").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), vaginal discharge ("vaginal discharge"), uterine pain ("uterus pain"), back pain ("lower back pain"), arthralgia ("hip pain"), hypoaesthesia ("numbness in her leg / numbness in her arms / numbness in extremities"), neck pain ("neck pain"), musculoskeletal pain ("shoulder pain"), paraesthesia ("tingling in her arms and hands / tingling in extremities"), premenstrual syndrome ("pms symptoms"), abdominal distension ("bloating"), swelling ("swelling"), fallopian tube spasm ("spasms in one of my fallopian tubes"), genital haemorrhage (seriousness criterion medically significant) and cystitis ("bladder infections").The patient was treated with surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes)), moisturizing eye drops and root canal and fillings.Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, bladder disorder, dysmenorrhoea, dyspareunia, premenstrual syndrome, abdominal distension, swelling, genital haemorrhage and cystitis had resolved, the autoimmune disorder, allergy to metals, female sexual dysfunction, urinary tract disorder, tooth disorder, fatigue, constipation, diarrhoea, alopecia, anxiety, mood altered, urinary tract infection, vulvovaginal mycotic infection, migraine, headache, nausea, rash, food allergy, allergic reaction to excipient, lipoma of breast, vaginal discharge, asthenopia, vision blurred, hypothyroidism, weight increased, uterine pain, back pain, arthralgia, hypoaesthesia, neck pain, musculoskeletal pain, paraesthesia and fallopian tube spasm outcome was unknown and the osteoarthritis was resolving.The reporter considered abdominal distension, allergic reaction to excipient, allergy to metals, alopecia, anxiety, arthralgia, asthenopia, autoimmune disorder, back pain, bladder disorder, constipation, cystitis, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube spasm, fatigue, female sexual dysfunction, food allergy, genital haemorrhage, headache, hypoaesthesia, hypothyroidism, lipoma of breast, menorrhagia, migraine, mood altered, musculoskeletal pain, nausea, neck pain, osteoarthritis, paraesthesia, pelvic pain, premenstrual syndrome, rash, swelling, tooth disorder, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: current weight 165 lbs.Discrepancy to be noted in essure insertion date as (b)(6) 2009.Expiration date of essure device: left - (b)(6)-2010 and right - (b)(6)2010.Essure devices were visualized in the endometrial cavity with 6 coils visible on the left and 3 coils visible on the right diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.6 kg/sqm.Hysterosalpingogram - in (b)(6) 2009: failure to occlude (close) fallopian tubes.; in (b)(6) 2009: total bilateral occlusion.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical: menorrhagia, vaginal hemorrhage, pelvic pain, anxiety, arthritis, hypothyroidism, dyspareunia, bladder disorder, constipation, diarrhea, headache and dysmenorrhea, urinary tract infection, abdominal pain.Most recent follow-up information incorporated above includes: on 16-apr-2019: pfs and mr were received: lot numbers were added.Events: genital hemorrhage, cystitis were added.Reporter causality comments were added.Reporters were added.Concomitant drugs and conditions were added.Historical drugs were added.Medical history were added.Lab data were added.Incident 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain / pain severe and persistent pain"), autoimmune disorder ("autoimmune disorder") and genital haemorrhage ("heavy bleeding") in an adult female patient who had essure (batch no.627296, 627735) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included tonsillitis, tonsillectomy, flank pain and adenomyosis.On unknown date hysterosalpingogram test showed, first test showed fallopian tubes were not closed off, second test showed they were.On (b)(6) 2017, positive depression screening.On a scale of 1 to 10, the patient rates the pain (pelvic pain) as 6.Previously administered products included for birth control: depo-provera from (b)(6) 2006 to (b)(6) 2007; for an unreported indication: antibiotics.Concurrent conditions included depression, unspecified vitamin deficiency, rectal pressure severe, uterine bleeding, adenomyosis, overweight, kidney infection, menstruation irregular, amenorrhoea, urinary frequency, anorexia, stiffness, dizziness, contact dermatitis, palpitations, dysuria, suprapubic pain, acute bronchitis, acute maxillary sinusitis, spondylosis, radiculopathy, vitamin b12 deficiency, urinary urgency, cold intolerance, decreased appetite, hypohidrosis, memory impaired, myalgia, shortness of breath, motor vehicle accident, neurogenic bladder, nocturia, uterine bleeding and tiredness.Concomitant products included alprazolam (xanax) since 2013, calamine;phenol (calamine lotion phenolated), diphenhydramine hydrochloride (benadryl), hydrocortisone, levothyroxine from 2015 to 2017, oxybutynin hydrochloride (ditropan) since 2015 and sertraline hydrochloride (zoloft) from 2009 to 2012.In 2008, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), migraine ("migraines") and headache ("headaches").On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2009, the patient experienced fatigue ("fatigue"), constipation ("constipation / gastrointestinal or digestive system condition - type: constipation"), diarrhoea ("diarrhea / gastrointestinal or digestive system condition - type: diarrhea"), anxiety ("increased anxiety / psychological or psychiatric problems - condition: anxiety") and mood altered ("moodiness, particularly during menstrual cycle").In 2010, the patient experienced allergy to metals ("allergic or hypersensitivity reaction / reaction to metal/ became allergic/sensitive to metals"), bladder disorder ("bladder problem or changes / bladder issues"), urinary tract disorder ("urinary problems or changes"), rash ("rashes / rashes over entire trunk of body"), food allergy ("reactions to wheat/ became allergic/sensitive to wheat") and allergic reaction to excipient ("reaction to dyes/ became allergic/sensitive to dyes").In (b)(6) 2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), vulvovaginal mycotic infection ("recurrent yeast infection") and nausea ("nausea").In 2012, the patient experienced asthenopia ("eye strain / vision/eye problems - type: eye strain") and vision blurred ("eye blurriness / vision/eye problems - type: blurriness").In 2013, the patient experienced tooth disorder ("dental problems") and was found to have weight increased ("weight gain/ weight gain / loss (specify which one) gain").In (b)(6) 2014, the patient experienced osteoarthritis ("degenerative arthritis / autoimmune disorder - type of disorder: degenerative arthritis") and autoimmune hypothyroidism ("hypothyroidism / autoimmune disorder - type of disorder: hypothyroidism").In (b)(6) 2015, the patient was found to have lipoma of breast ("lipoma breast / tumor / teratoma / cancer - type: lipoma, breast").On an unknown date, the patient experienced autoimmune disorder (seriousness criterion medically significant), vaginal discharge ("vaginal discharge"), uterine pain ("uterus pain"), back pain ("lower back pain"), arthralgia ("hip pain"), hypoaesthesia ("numbness in her leg / numbness in her arms / numbness in extremities"), neck pain ("neck pain"), musculoskeletal pain ("shoulder pain"), paraesthesia ("tingling in her arms and hands / tingling in extremities"), premenstrual syndrome ("pms symptoms"), abdominal distension ("bloating"), swelling ("swelling"), fallopian tube spasm ("spasms in one of my fallopian tubes"), genital haemorrhage (seriousness criterion medically significant) and cystitis ("bladder infections").The patient was treated with surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes)), moisturizing eye drops and root canal and fillings.Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, bladder disorder, dysmenorrhoea, dyspareunia, premenstrual syndrome, abdominal distension, swelling, genital haemorrhage and cystitis had resolved, the autoimmune disorder, allergy to metals, female sexual dysfunction, urinary tract disorder, tooth disorder, fatigue, constipation, diarrhoea, alopecia, anxiety, mood altered, urinary tract infection, vulvovaginal mycotic infection, migraine, headache, nausea, rash, food allergy, allergic reaction to excipient, lipoma of breast, vaginal discharge, asthenopia, vision blurred, autoimmune hypothyroidism, weight increased, uterine pain, back pain, arthralgia, hypoaesthesia, neck pain, musculoskeletal pain, paraesthesia and fallopian tube spasm outcome was unknown and the osteoarthritis was resolving.The reporter considered abdominal distension, allergic reaction to excipient, allergy to metals, alopecia, anxiety, arthralgia, asthenopia, autoimmune disorder, autoimmune hypothyroidism, back pain, bladder disorder, constipation, cystitis, diarrhoea, dysmenorrhoea, dyspareunia, fallopian tube spasm, fatigue, female sexual dysfunction, food allergy, genital haemorrhage, headache, hypoaesthesia, lipoma of breast, menorrhagia, migraine, mood altered, musculoskeletal pain, nausea, neck pain, osteoarthritis, paraesthesia, pelvic pain, premenstrual syndrome, rash, swelling, tooth disorder, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: current weight (b)(6).Discrepancy to be noted in essure insertion date as (b)(6) 2009.Expiration date of essure device: left - (b)(6) 2010 and right - 30-may-2010.Essure devices were visualized in the endometrial cavity with 6 coils visible on the left and 3 coils visible on the right diagnostic results (normal ranges are provided in parenthesis if available): body mass index was (b)(6).Hysterosalpingogram - in (b)(6) 2009: failure to occlude (close) fallopian tubes.; in (b)(6) 2009: total bilateral occlusion.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical: menorrhagia, vaginal hemorrhage, pelvic pain, anxiety, arthritis, hypothyroidism, dyspareunia, bladder disorder, constipation, diarrhea, headache and dysmenorrhea, urinary tract infection, abdominal pain lot number:627296 manufacture date:2008/05 expiration date: 2010/05 lot number:627735 manufacture date:2008/07 expiration date: 2010/07 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 complaint incident 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.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain / pain severe and persistent pain') and genital haemorrhage ('heavy bleeding') in an adult female patient who had essure (batch no.627296, 627735) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included tonsillitis, tonsillectomy, flank pain and adenomyosis.On unknown date hysterosalpingogram test showed, first test showed fallopian tubes were not closed off, second test showed they were.On (b)(6)2017, positive depression screening.On a scale of 1 to 10, the patient rates the pain (pelvic pain) as 6.Previously administered products included for birth control: depo-provera from (b)(6)2006 to (b)(6)2007; for an unreported indication: antibiotics.Concurrent conditions included depression, unspecified vitamin deficiency, rectal pressure severe, uterine bleeding, adenomyosis, overweight, kidney infection, menstruation irregular, amenorrhoea, urinary frequency, anorexia, stiffness, dizziness, contact dermatitis, palpitations, dysuria, suprapubic pain, acute bronchitis, acute maxillary sinusitis, spondylosis, radiculopathy, vitamin b12 deficiency, urinary urgency, cold intolerance, decreased appetite, hypohidrosis, memory impaired, myalgia, shortness of breath, motor vehicle accident, neurogenic bladder, nocturia, uterine bleeding and tiredness.Concomitant products included alprazolam (xanax) since 2013, calamine;phenol (calamine lotion phenolated), diphenhydramine hydrochloride (benadryl), hydrocortisone, levothyroxine from 2015 to 2017, oxybutynin hydrochloride (ditropan) since 2015 and sertraline hydrochloride (zoloft) from 2009 to 2012.On (b)(6)2008, the patient had essure inserted.In 2008, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), migraine ("migraines") and headache ("headaches").In (b)(6)2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).In 2009, the patient experienced fatigue ("fatigue"), constipation ("constipation / gastrointestinal or digestive system condition - type: constipation"), diarrhoea ("diarrhea / gastrointestinal or digestive system condition - type: diarrhea"), anxiety ("increased anxiety / psychological or psychiatric problems - condition: anxiety") and mood altered ("moodiness, particularly during menstrual cycle").In 2010, the patient experienced allergy to metals ("allergic or hypersensitivity reaction / reaction to metal/ became allergic/sensitive to metals"), bladder disorder ("bladder problem or changes / bladder issues"), urinary tract disorder ("urinary problems or changes"), rash ("rashes / rashes over entire trunk of body"), food allergy ("reactions to wheat/ became allergic/sensitive to wheat") and allergic reaction to excipient ("reaction to dyes/ became allergic/sensitive to dyes").In (b)(6)2010, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2011, the patient experienced alopecia ("hair loss"), urinary tract infection ("urinary tract infection"), vulvovaginal mycotic infection ("recurrent yeast infection") and nausea ("nausea, nauseous").In 2012, the patient experienced asthenopia ("eye strain / vision/eye problems - type: eye strain") and vision blurred ("eye blurriness / vision/eye problems - type: blurriness").In 2013, the patient experienced tooth disorder ("dental problems") and was found to have weight increased ("weight gain/ weight gain / loss (specify which one) gain").In (b)(6)2014, the patient experienced osteoarthritis ("degenerative arthritis / autoimmune disorder - type of disorder: degenerative arthritis") and autoimmune hypothyroidism ("hypothyroidism / autoimmune disorder - type of disorder: hypothyroidism").In (b)(6)2015, the patient was found to have lipoma of breast ("lipoma breast / tumor / teratoma / cancer - type: lipoma, breast").On an unknown date, the patient experienced autoimmune disorder ("autoimmune disorder"), vaginal discharge ("vaginal discharge"), uterine pain ("uterus pain"), back pain ("lower back pain"), arthralgia ("hip pain"), hypoaesthesia ("numbness in her leg / numbness in her arms / numbness in extremities"), neck pain ("neck pain"), musculoskeletal pain ("shoulder pain"), paraesthesia ("tingling in her arms and hands / tingling in extremities"), premenstrual syndrome ("pms symptoms"), abdominal distension ("bloating"), swelling ("swelling"), fallopian tube spasm ("spasms in one of my fallopian tubes"), genital haemorrhage (seriousness criterion medically significant), cystitis ("bladder infections"), amenorrhoea ("no longer get a period"), gluten sensitivity ("gluten sensitivity"), arthritis ("arthritis"), gastric disorder ("stomach issues"), dyspepsia ("heartburn") and flatulence ("horribly gassy").The patient was treated with surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes)), moisturizing eye drops and root canal and fillings.Essure was removed on (b)(6)2017.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, bladder disorder, dysmenorrhoea, dyspareunia, premenstrual syndrome, abdominal distension, swelling, genital haemorrhage and cystitis had resolved, the autoimmune disorder, allergy to metals, female sexual dysfunction, urinary tract disorder, tooth disorder, fatigue, constipation, diarrhoea, alopecia, anxiety, mood altered, urinary tract infection, vulvovaginal mycotic infection, migraine, headache, nausea, rash, food allergy, allergic reaction to excipient, lipoma of breast, vaginal discharge, asthenopia, vision blurred, autoimmune hypothyroidism, weight increased, uterine pain, back pain, arthralgia, hypoaesthesia, neck pain, musculoskeletal pain, paraesthesia, fallopian tube spasm, amenorrhoea, dyspepsia and flatulence outcome was unknown, the osteoarthritis and gluten sensitivity was resolving and the arthritis had not resolved.The reporter considered abdominal distension, allergic reaction to excipient, allergy to metals, alopecia, amenorrhoea, anxiety, arthralgia, arthritis, asthenopia, autoimmune disorder, autoimmune hypothyroidism, back pain, bladder disorder, constipation, cystitis, diarrhoea, dysmenorrhoea, dyspareunia, dyspepsia, fallopian tube spasm, fatigue, female sexual dysfunction, flatulence, food allergy, gastric disorder, genital haemorrhage, gluten sensitivity, headache, hypoaesthesia, lipoma of breast, menorrhagia, migraine, mood altered, musculoskeletal pain, nausea, neck pain, osteoarthritis, paraesthesia, pelvic pain, premenstrual syndrome, rash, swelling, tooth disorder, urinary tract disorder, urinary tract infection, uterine pain, vaginal discharge, vaginal haemorrhage, vision blurred, vulvovaginal mycotic infection and weight increased to be related to essure.The reporter commented: current weight 165 lbs.Discrepancy to be noted in essure insertion date as (b)(6)2009.Expiration date of essure device: left - (b)(6)2010 and right - (b)(6)2010.Essure devices were visualized in the endometrial cavity with 6 coils visible on the left and 3 coils visible on the right.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.6 kg/sqm.Hysterosalpingogram - in (b)(6)2009: failure to occlude (close) fallopian tubes.; in (b)(6)2009: total bilateral occlusion.¿concerning the injuries reported in this case, the following ones were described in patient¿s medical: menorrhagia, vaginal hemorrhage, pelvic pain, anxiety, arthritis, hypothyroidism, dyspareunia, bladder disorder, constipation, diarrhea, headache and dysmenorrhea, urinary tract infection, abdominal pain.Lot number:627296 manufacture date:2008/05 expiration date: 2010/05.Lot number:627735 manufacture date:2008/07 expiration date: 2010/07.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: content of social media received.New events of amenorrhea, gluten sensitivity, arthritis and gastric disorder, heartburn and horribly gassy were added.Reporter added.On 23-mar-2020: fu 12 and fu 13 processed together.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.
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