| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Chest Pain (1776); Cyst(s) (1800); Diarrhea (1811); Emotional Changes (1831); Erythema (1840); Flatus (1865); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Pain (1994); Tinnitus (2103); Vomiting (2144); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Myalgia (2238); Urticaria (2278); Arthralgia (2355); Numbness (2415); Palpitations (2467); Shaking/Tremors (2515); Sleep Dysfunction (2517); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191); Constipation (3274)
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| Event Date 05/01/2012 |
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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 ("pelvic pain (chronic)") and cervical dysplasia ("cervical dysplasia") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included abortion (for personal reasons) in (b)(6) 2011, multigravida, parity 4 ((b)(6) 1997, (b)(6) 2000, (b)(6) 2002, and (b)(6) 2006), recurrent abortion and pulmonary embolism (hospital admission for 5 days) in (b)(6) 2011.Concurrent conditions included allergy to metals since 1983 and underweight.Concomitant products included salbutamol sulfate (ventolin hfa) in 1987 for allergic asthma and conlunett (ortho-novum) on (b)(6) 2011 for contraception.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced hypersensitivity ("allergic reaction persistent and painful hives all over my body hives") with urticaria and pain of skin.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), the first episode of back pain ("pain in back") and arthralgia ("pain in joint (persistent)").In (b)(6) 2012, the patient experienced adnexa uteri pain ("ovaries (persistent stabbing, cramping, burning)") and the second episode of back pain ("lower back (persistent aching searing lower back)").In (b)(6) 2013, the patient experienced cervical dysplasia (seriousness criterion medically significant).On an unknown date, the patient experienced dyspareunia ("painful intercourse"), menorrhagia ("heavy menstrual flow"), feeling abnormal ("bain fog"), myalgia ("muscle aches"), adenomyosis ("adenomyosis") and ovulation pain ("ovulatory pain").On an unknown date, the patient experienced metrorrhagia (¿bleeding between periods¿), micturition urgency (¿urgent/frequent urination¿), pollakiuria (¿urgent/frequent urination¿), urinary tract infection (¿utis¿), burning sensation (¿burning¿), pain (¿stinging nos¿), vulvovaginal pain (¿stabbing at vaginal entrance¿), breast pain (¿breast pain/tenderness¿), breast tenderness (¿breast pain/tenderness¿), muscle spasms (¿abdominal spasms/twitching/fluttering¿), chest pain (¿pain in chest¿), pain in extremity (¿pain in leg¿), neck pain (¿pain in neck¿), spinal pain (¿pain in spine¿), (¿pain in hip¿) arthralgia, pain (¿all over body aches/pain/ severe and persistent pain¿), gastrointestinal disorder (¿gastrointestinal issues/ bowel issues¿), nausea (¿nausea¿), vomiting (¿vomiting¿), flatulence (¿gas¿), constipation (¿constipation¿), diarrhoea (¿diarrhea¿), abdominal distension (¿severe bloating¿), dysgeusia (¿metallic taste in mouth¿), dyspepsia (¿heartburn¿), nervous system disorder (¿neurological issues¿), headache (¿headaches¿), migraine (¿migraines¿), dizziness (¿dizziness¿), anxiety (¿anxiety attacks¿), panic attack (¿panic attacks¿), mood swings (¿mood swings¿), tinnitus (¿ringing in ears¿), hypoaesthesia (¿numbness in thigh¿), paraesthesia (¿numbness and tingling in extremities¿), neuralgia (¿nerve pain¿), tremor (¿tremors/ shakiness¿), increased tendency to bruise (¿easily bruising¿), cyst (¿cysts¿), furuncle (¿boils¿), acne (¿acne¿), palpitations (¿heart palpitations¿), hair growth abnormal (¿unusual hair growth¿), tooth disorder (¿dental issues¿), insomnia (¿insomnia¿), weight increased (¿weight gain¿), visual impairment (¿vision problems¿), allergy to metals (¿allergic to nickel/ hypersensitivity reaction to nickel¿) with rash erythematous, mental disorder (¿aggravated psychiatric and/or psychological conditions¿), and multiple allergies (¿multiple allergies/ allergic symptoms¿) with multiple chemical sensitivity, food allergy, and gluten sensitivity.The patient was treated with cetirizine hydrochloride (zyrtec), surgery (bilateral salpingectomy with tubo-uterine anastomosis and essure removal) and surgery (colposcopy and leep (loop electrosurgical excision procedure) in (b)(6) 2013).Essure was removed on (b)(6) 2013.On (b)(6) 2013, the adnexa uteri pain and the last episode of back pain had resolved.In (b)(6) 2013, the pelvic pain, hypersensitivity and feeling abnormal had resolved.In (b)(6) 2013, the menorrhagia and ovulation pain had resolved.At the time of the report, dyspareunia, metrorrhagia, micturition urgency, pollakiuria, urinary tract infection, burning sensation, pain, vulvovaginal pain, breast pain, breast, tenderness, muscle spasms, chest pain, pain in extremity, neck pain, spinal pain, pain, gastrointestinal disorder, nausea, vomiting, flatulence, diarrhoea, abdominal distension, dysgeusia, dyspepsia, nervous system disorder, headache, migraine, dizziness, anxiety, panic attack, mood swings, tinnitus, hypoaesthesia, paraesthesia, neuralgia, tremor, increased tendency to bruise, cyst, furuncle, acne, palpitations, hair growth abnormal, tooth disorder, insomnia, weight increased, visual impairment, allergy to metals, and mental disorder, had resolved and the cervical dysplasia, arthralgia, myalgia, the second episode of arthralgia, adenomyosis, and multiple allergies had not resolved.The reporter considered adenomyosis, adnexa uteri pain, arthralgia, cervical dysplasia, dyspareunia, feeling abnormal, hypersensitivity, menorrhagia, myalgia, ovulation pain, pelvic pain, the first episode of back pain, the second episode of back pain, metrorrhagia, micturition urgency, pollakiuria, urinary tract infection, burning sensation, pain, vulvovaginal pain, breast pain, breast, tenderness, muscle spasms, chest pain, pain in extremity, neck pain, spinal pain, pain, gastrointestinal disorder, nausea, vomiting, flatulence, diarrhoea, abdominal distension, dysgeusia, dyspepsia, nervous system disorder, headache, migraine, dizziness, anxiety, panic attack, mood swings, tinnitus, hypoaesthesia, paraesthesia, neuralgia, tremor, increased tendency to bruise, cyst, furuncle, acne, palpitations, hair growth abnormal, tooth disorder, insomnia, weight increased, visual impairment, the second episode of arthralgia, allergy to metals, mental disorder, and multiple allergies to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that she was treated with topical cream for allergic symptoms.She did not claim that essure worsened a previously existing injury/condition.On (b)(6) 2014 she made a complaint on the fda (u.S.Food and drug administration) website (report number mw5035547).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: result showed successful blockage.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 pelvic pain ("pelvic pain (chronic)"), thrombosis ("blood clots") and cervical dysplasia ("cervical dysplasia/ cervical dysplasia") in a 33-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included abortion (for personal reasons) in (b)(6) 2011, multigravida, parity 4 ((b)(6) 1997, (b)(6) 2000, (b)(6) 2002, and (b)(6) 2006), recurrent abortion, pulmonary embolism (hospital admission for 5 days) in (b)(6) 2011 and sterilisation reversal.Concurrent conditions included allergy to metals since 1983, underweight and herpes zoster.Concomitant products included salbutamol sulfate (ventolin hfa) since 1987 for allergic asthma and conlunett (ortho-novum) from 15-may-2011 to 18-aug-2012 for contraception.On (b)(6) 2012, the patient had essure inserted.On the same day, the patient experienced hypersensitivity ("allergic reaction persistent and painful hives all over my body hives") with urticaria, pain of skin and pruritus.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), the first episode of back pain ("pain in back") and the first episode of arthralgia ("pain in joint (persistent)").In (b)(6) 2012, the patient experienced adnexa uteri pain ("ovaries (persistent stabbing, cramping, burning)") and the second episode of back pain ("lower back (persistent aching searing lower back)").In (b)(6) 2013, the patient experienced cervical dysplasia (seriousness criterion medically significant).On an unknown date, the patient experienced thrombosis (seriousness criterion medically significant), dyspareunia ("painful intercourse/painful intercourse"), menorrhagia ("heavy menstrual flow/ long menstrual cycles"), feeling abnormal ("brain fog"), myalgia ("muscle aches"), adenomyosis ("adenomyosis"), ovulation pain ("ovulatory pain"), metrorrhagia ("bleeding between periods/bleeding between periods"), micturition urgency ("urgent/frequent urination/ urgent/frequent urination"), pollakiuria ("urgent/frequent urination"), urinary tract infection ("utis/utls"), burning sensation ("burning/ burning"), the first episode of pain ("stinging nos/stinging"), vulvovaginal pain ("stabbing at vaginal entrance/stabbing at vaginal entrance"), breast pain ("breast pain/tenderness"), breast tenderness ("breast pain/tenderness/tenderness"), muscle spasms ("abdominal spasms/twitching/fluttering/abdominal spasms/ twitching/ fluttering"), chest pain ("pain in chest/pain in chest"), pain in extremity ("pain in leg/pain in legs"), neck pain ("pain in neck/pain in neck"), spinal pain ("pain in spine/pain in spine"), the second episode of arthralgia ("pain in hip/pain in hip"), the second episode of pain ("all over body aches/pain/ severe and persistent pain/all over body aches/pain"), gastrointestinal disorder ("gastrointestinal issues/ bowel issues/gastrointestinal issues"), nausea ("nausea"), vomiting ("vomiting"), flatulence ("gas"), constipation ("constipation"), diarrhoea ("diarrhea"), abdominal distension ("severe bloating"), dysgeusia ("metallic taste in mouth"), dyspepsia ("heartburn"), nervous system disorder ("neurological issues"), headache ("headaches"), migraine ("migraines"), dizziness ("dizziness"), anxiety ("anxiety attacks"), panic attack ("panic attacks"), mood swings ("mood swings/mood swings"), tinnitus ("ringing in ears/ringing in ears"), hypoaesthesia ("numbness in thigh/numbness in thigh"), paraesthesia ("numbness and tingling in extremities/numbness and tingling in extremities"), neuralgia ("nerve pain/nerve pain"), tremor ("tremors/ shakiness/"), increased tendency to bruise ("easily bruising/easily bruising"), cyst ("cysts/cysts"), furuncle ("boils/boils"), acne ("acne?acne"), palpitations ("heart palpitations/heart palpitation"), hair growth abnormal ("unusual hair growth/unusual hair growth"), tooth disorder ("dental issues/dental issues"), insomnia ("insomnia/insomnia"), weight increased ("weight gain/weight gain"), visual impairment ("vision problems/vision problem"), allergy to metals ("allergic to nickel/ hypersensitivity reaction to nickel") with rash erythematous, mental disorder ("aggravated psychiatric and/or psychological conditions/aggravated psychaictric and/or psychological issues") and multiple allergies ("multiple allergies/ allergic symptoms") with multiple chemical sensitivity, food allergy and gluten sensitivity.The patient was treated with cetirizine hydrochloride (zyrtec), surgery (bilateral salpingectomy with tubo-uterine anastomosis and essure removal) and surgery (colposcopy and leep (loop electrosurgical excision procedure) in (b)(6) 2013).Essure was removed on (b)(6) 2013.On (b)(6) 2013, the adnexa uteri pain and the last episode of back pain had resolved.In (b)(6) 2013, the pelvic pain, hypersensitivity and feeling abnormal had resolved.In (b)(6) 2013, the menorrhagia and ovulation pain had resolved.At the time of the report, the thrombosis outcome was unknown, the cervical dysplasia, myalgia, adenomyosis, the last episode of arthralgia and multiple allergies had not resolved and the dyspareunia, metrorrhagia, micturition urgency, pollakiuria, urinary tract infection, burning sensation, vulvovaginal pain, breast pain, breast tenderness, muscle spasms, chest pain, pain in extremity, neck pain, spinal pain, the last episode of pain, gastrointestinal disorder, nausea, vomiting, flatulence, constipation, diarrhoea, abdominal distension, dysgeusia, dyspepsia, nervous system disorder, headache, migraine, dizziness, anxiety, panic attack, mood swings, tinnitus, hypoaesthesia, paraesthesia, neuralgia, tremor, increased tendency to bruise, cyst, furuncle, acne, palpitations, hair growth abnormal, tooth disorder, insomnia, weight increased, visual impairment, allergy to metals and mental disorder had resolved.The reporter considered abdominal distension, acne, adenomyosis, adnexa uteri pain, allergy to metals, anxiety, breast pain, breast tenderness, burning sensation, cervical dysplasia, chest pain, constipation, cyst, diarrhoea, dizziness, dysgeusia, dyspareunia, dyspepsia, feeling abnormal, flatulence, furuncle, gastrointestinal disorder, hair growth abnormal, headache, hypersensitivity, hypoaesthesia, increased tendency to bruise, insomnia, menorrhagia, mental disorder, metrorrhagia, micturition urgency, migraine, mood swings, multiple allergies, muscle spasms, myalgia, nausea, neck pain, nervous system disorder, neuralgia, ovulation pain, pain in extremity, palpitations, panic attack, paraesthesia, pelvic pain, pollakiuria, spinal pain, thrombosis, tinnitus, tooth disorder, tremor, urinary tract infection, visual impairment, vomiting, vulvovaginal pain, weight increased, the first episode of arthralgia, the first episode of back pain, the first episode of pain, the second episode of arthralgia, the second episode of back pain and the second episode of pain to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that she was treated with topical cream for allergic symptoms.She claims that her use of essure caused or aggravated psychiatric and/or psychological conditions.She did not claim that essure worsened a previously existing injury/condition.On (b)(6) 2014 she made a complaint on the fda (u.S.Food and drug administration) website (report number mw (b)(4)).Plaintiff wanted her body back to being anatomically correct diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 18 kg/sqm.Hysterosalpingogram - on (b)(6) 2012: result showed successful blockage.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records : rash on the right side of the neck, blood clots.Most recent follow-up information incorporated above includes: on 4-sep-2018: pfs received.New event, "blood clots" was added.Historical condition was added.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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Search Alerts/Recalls
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