| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Anemia (1706); Arthritis (1723); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Memory Loss/Impairment (1958); Pain (1994); Pelvic Inflammatory Disease (2000); Swelling (2091); Tinnitus (2103); Dizziness (2194); Anxiety (2328); Depression (2361); Loss of consciousness (2418); Abdominal Cramps (2543); Heavier Menses (2666); No Code Available (3191)
|
|
Event Type
Injury
|
|
Event Description
|
|
This case was initially received via regulatory authority (fda, reference number: mw5077433) on 07-jun-2018.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure (batch no.869748) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included colecalciferol (vitamin d) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal periods"), amenorrhoea ("skipped periods"), menorrhagia ("heavy periods"), abdominal pain ("severe cramping abdominal"), ovulation pain ("painful ovulation"), loss of libido ("loss of sex drive"), dyspareunia ("painful intercourse"), incontinence ("incontinence"), migraine ("migraines"), coccydynia ("constant stabbing pain at tip of tailbone"), arthritis ("arthritis"), feeling abnormal ("brain fog"), goitre ("enlarged thyroid"), food allergy ("food sensitivities"), hypersensitivity ("severe allergic reactions"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), depression ("depressions"), hypoaesthesia ("numbness"), paraesthesia ("tingling in arms and legs"), tinnitus ("especially during ovulation ringing in ears"), dental caries ("tooth decay"), alopecia ("hair loss"), dizziness ("dizziness"), loss of consciousness ("blackouts"), fatigue ("chronic fatigue"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), vitamin b12 deficiency ("vitamin b12 deficiency"), contusion ("unexplained bruising"), gluten sensitivity ("gluten sensitivity"), psoriasis ("psoriasis"), peripheral swelling ("swelling of feet and hands"), lymphadenopathy ("swollen glands") and abdominal distension ("severe bloating").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menstrual disorder, amenorrhoea, menorrhagia, abdominal pain, ovulation pain, loss of libido, dyspareunia, incontinence, migraine, coccydynia, arthritis, feeling abnormal, goitre, food allergy, hypersensitivity, gastrointestinal disorder, anxiety, depression, hypoaesthesia, paraesthesia, tinnitus, dental caries, alopecia, dizziness, loss of consciousness, fatigue, anaemia, vitamin d deficiency, vitamin b12 deficiency, contusion, gluten sensitivity, psoriasis, peripheral swelling, lymphadenopathy and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, alopecia, amenorrhoea, anaemia, anxiety, arthritis, coccydynia, contusion, dental caries, depression, dizziness, dyspareunia, fatigue, feeling abnormal, food allergy, gastrointestinal disorder, gluten sensitivity, goitre, hypersensitivity, hypoaesthesia, incontinence, loss of consciousness, loss of libido, lymphadenopathy, menorrhagia, menstrual disorder, migraine, ovulation pain, paraesthesia, pelvic pain, peripheral swelling, psoriasis, tinnitus, vitamin b12 deficiency and vitamin d deficiency to be related to essure.Incident at the time of reporting, 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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (fda, reference number: mw5077433) on 07-jun-2018.The most recent information was received on 31-oct-2018.Quality-safety evaluation of ptc: unable to confirm complaint this spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pain") in a female patient who had essure (batch no.869748) inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included colecalciferol (vitamin d) and multivitamin.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menstrual disorder ("abnormal periods"), amenorrhoea ("skipped periods"), menorrhagia ("heavy periods"), abdominal pain ("severe cramping abdominal"), ovulation pain ("painful ovulation"), loss of libido ("loss of sex drive"), dyspareunia ("painful intercourse"), incontinence ("incontinence"), migraine ("migraines"), coccydynia ("constant stabbing pain at tip of tailbone"), arthritis ("arthritis"), feeling abnormal ("brain fog"), goitre ("enlarged thyroid"), food allergy ("food sensitivities"), hypersensitivity ("severe allergic reactions"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), depression ("depressions"), hypoaesthesia ("numbness"), paraesthesia ("tingling in arms and legs"), tinnitus ("especially during ovulation ringing in ears"), dental caries ("tooth decay"), alopecia ("hair loss"), dizziness ("dizziness"), loss of consciousness ("blackouts"), fatigue ("chronic fatigue"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), vitamin b12 deficiency ("vitamin b12 deficiency"), contusion ("unexplained bruising"), gluten sensitivity ("gluten sensitivity"), psoriasis ("psoriasis"), peripheral swelling ("swelling of feet and hands"), lymphadenopathy ("swollen glands") and abdominal distension ("severe bloating").The patient was treated with surgery (essure removal).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, menstrual disorder, amenorrhoea, menorrhagia, abdominal pain, ovulation pain, loss of libido, dyspareunia, incontinence, migraine, coccydynia, arthritis, feeling abnormal, goitre, food allergy, hypersensitivity, gastrointestinal disorder, anxiety, depression, hypoaesthesia, paraesthesia, tinnitus, dental caries, alopecia, dizziness, loss of consciousness, fatigue, anaemia, vitamin d deficiency, vitamin b12 deficiency, contusion, gluten sensitivity, psoriasis, peripheral swelling, lymphadenopathy and abdominal distension outcome was unknown.The reporter considered abdominal distension, abdominal pain, alopecia, amenorrhoea, anaemia, anxiety, arthritis, coccydynia, contusion, dental caries, depression, dizziness, dyspareunia, fatigue, feeling abnormal, food allergy, gastrointestinal disorder, gluten sensitivity, goitre, hypersensitivity, hypoaesthesia, incontinence, loss of consciousness, loss of libido, lymphadenopathy, menorrhagia, menstrual disorder, migraine, ovulation pain, paraesthesia, pelvic pain, peripheral swelling, psoriasis, tinnitus, vitamin b12 deficiency and vitamin d deficiency to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-2018: quality safety evaluation of ptc- product technical complaint.Incident: at the time of reporting, 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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (fda, reference number: mw5077433) on 07-jun-2018.The most recent information was received on 22-nov-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic infection ('infection (other) describe: pelvic') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.869748) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included arthritis (foot surgery).Concomitant products included vitamin d nos (vitamin d) and vitamins nos (multivitamin).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced memory impairment ("forgetfulness").In (b)(6) 2012, the patient experienced fungal infection ("yeast infection").In (b)(6) 2013, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2013, the patient experienced back pain ("back pain/ lower back pain") and pain in extremity ("toe pain").In (b)(6) 2013, the patient experienced dental caries ("tooth decay").On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), amenorrhoea ("skipped periods"), menorrhagia ("heavy periods\soaking through a pad in less than 15 mins\menorrhagia (heavy menstrual bleeding)"), abdominal pain ("severe cramping abdominal"), ovulation pain ("painful ovulation"), loss of libido ("loss of sex drive"), dyspareunia ("painful intercourse"), incontinence ("incontinence"), migraine ("migraines"), coccydynia ("constant stabbing pain at tip of tailbone"), arthritis ("arthritis"), feeling abnormal ("brain fog"), goitre ("enlarged thyroid"), food allergy ("food sensitivities"), hypersensitivity ("severe allergic reactions"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), depression ("depressions"), hypoaesthesia ("numbness"), paraesthesia ("tingling in arms and legs"), tinnitus ("especially during ovulation ringing in ears"), alopecia ("hair loss"), dizziness ("dizziness"), loss of consciousness ("blackouts"), fatigue ("chronic fatigue"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), vitamin b12 deficiency ("vitamin b12 deficiency"), contusion ("unexplained bruising"), gluten sensitivity ("gluten sensitivity/gluten intolerence"), psoriasis ("psoriasis"), peripheral swelling ("swelling of feet and hands"), lymphadenopathy ("swollen glands"), abdominal distension ("severe bloating"), abdominal pain lower ("lower abdominal pain"), skin candida ("cutaneous candidiasis"), vulvovaginal discomfort ("vaginal irritation"), vaginal infection ("vaginal infection"), pollakiuria ("urinary frequency"), lethargy ("lethargy"), osteoarthritis ("arthritis in both big toe joints"), tooth demineralisation ("loss of calcification of bones and teeth") and bone decalcification ("loss of calcification of bones and teeth").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic infection, amenorrhoea, menorrhagia, ovulation pain, loss of libido, dyspareunia, incontinence, migraine, coccydynia, arthritis, feeling abnormal, goitre, food allergy, hypersensitivity, anxiety, depression, hypoaesthesia, paraesthesia, tinnitus, alopecia, dizziness, loss of consciousness, anaemia, vitamin d deficiency, vitamin b12 deficiency, contusion, peripheral swelling, lymphadenopathy, abdominal distension, vaginal haemorrhage, fungal infection, pain in extremity, skin candida, vulvovaginal discomfort and vaginal infection outcome was unknown, the pelvic pain, abdominal pain, dental caries, fatigue, dysmenorrhoea, back pain, memory impairment, abdominal pain lower, pollakiuria, lethargy, osteoarthritis, tooth demineralisation and bone decalcification had resolved and the gastrointestinal disorder, gluten sensitivity and psoriasis was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, amenorrhoea, anaemia, anxiety, arthritis, back pain, bone decalcification, coccydynia, contusion, dental caries, depression, dizziness, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, food allergy, fungal infection, gastrointestinal disorder, gluten sensitivity, goitre, hypersensitivity, hypoaesthesia, incontinence, lethargy, loss of consciousness, loss of libido, lymphadenopathy, memory impairment, menorrhagia, migraine, osteoarthritis, ovulation pain, pain in extremity, paraesthesia, pelvic infection, pelvic pain, peripheral swelling, pollakiuria, psoriasis, skin candida, tinnitus, tooth demineralisation, vaginal haemorrhage, vaginal infection, vitamin b12 deficiency, vitamin d deficiency and vulvovaginal discomfort to be related to essure.The reporter commented: received treatment for- vaginal infection, urinary frequency, lethargy, arthritis in both big toe joints, loss of calcification of bones and teeth, pelvic pain abdominal pain, back pain, dysmenorrhea, menorrhagia, rash/skin condition, fatigue.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: result: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-nov-2019: pfs received: new events- vaginal infection, urinary frequency, lethargy, arthritis in both big toe joints, loss of calcification of bones and teeth, were added.Outcomes 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.
|
| |
|
Manufacturer Narrative
|
|
This case was initially received via regulatory authority (fda, reference number: mw5077433) on 07-jun-2018.The most recent information was received on 22-oct-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic infection ('infection (other) describe: pelvic') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.869748) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included arthritis (foot surgery).Concomitant products included vitamin d nos (vitamin d) and vitamins nos (multivitamin).On (b)(6) 2011, the patient had essure inserted.In (b)(6) 2012, the patient experienced memory impairment ("forgetfulness").In (b)(6) 2012, the patient experienced fungal infection ("yeast infection").In (b)(6) 2013, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)") and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2013, the patient experienced back pain ("back pain/ lower back pain") and pain in extremity ("toe pain").In (b)(6) 2013, the patient experienced dental caries ("tooth decay").On an unknown date, the patient experienced pelvic infection (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), amenorrhoea ("skipped periods"), menorrhagia ("heavy periods\soaking through a pad in less than 15 mins"), abdominal pain ("severe cramping abdominal"), ovulation pain ("painful ovulation"), loss of libido ("loss of sex drive"), dyspareunia ("painful intercourse"), incontinence ("incontinence"), migraine ("migraines"), coccydynia ("constant stabbing pain at tip of tailbone"), arthritis ("arthritis"), feeling abnormal ("brain fog"), goitre ("enlarged thyroid"), food allergy ("food sensitivities"), hypersensitivity ("severe allergic reactions"), gastrointestinal disorder ("bowel issues"), anxiety ("anxiety"), depression ("depressions"), hypoaesthesia ("numbness"), paraesthesia ("tingling in arms and legs"), tinnitus ("especially during ovulation ringing in ears"), alopecia ("hair loss"), dizziness ("dizziness"), loss of consciousness ("blackouts"), fatigue ("chronic fatigue"), anaemia ("anemia"), vitamin d deficiency ("vitamin d deficiency"), vitamin b12 deficiency ("vitamin b12 deficiency"), contusion ("unexplained bruising"), gluten sensitivity ("gluten sensitivity/gluten intolerence"), psoriasis ("psoriasis"), peripheral swelling ("swelling of feet and hands"), lymphadenopathy ("swollen glands"), abdominal distension ("severe bloating"), abdominal pain lower ("lower abdominal pain"), skin candida ("cutaneous candidiasis") and vulvovaginal discomfort ("vaginal irritation").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic infection, pelvic pain, amenorrhoea, menorrhagia, ovulation pain, loss of libido, dyspareunia, incontinence, migraine, coccydynia, arthritis, feeling abnormal, goitre, food allergy, hypersensitivity, anxiety, depression, hypoaesthesia, paraesthesia, tinnitus, alopecia, dizziness, loss of consciousness, anaemia, vitamin d deficiency, vitamin b12 deficiency, contusion, peripheral swelling, lymphadenopathy, abdominal distension, vaginal haemorrhage, fungal infection, dysmenorrhoea, back pain, pain in extremity, skin candida and vulvovaginal discomfort outcome was unknown, the abdominal pain, dental caries, fatigue, memory impairment and abdominal pain lower had resolved and the gastrointestinal disorder, gluten sensitivity and psoriasis was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, amenorrhoea, anaemia, anxiety, arthritis, back pain, coccydynia, contusion, dental caries, depression, dizziness, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, food allergy, fungal infection, gastrointestinal disorder, gluten sensitivity, goitre, hypersensitivity, hypoaesthesia, incontinence, loss of consciousness, loss of libido, lymphadenopathy, memory impairment, menorrhagia, migraine, ovulation pain, pain in extremity, paraesthesia, pelvic infection, pelvic pain, peripheral swelling, psoriasis, skin candida, tinnitus, vaginal haemorrhage, vitamin b12 deficiency, vitamin d deficiency and vulvovaginal discomfort to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: result: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 22-oct-2019: pfs and mr received :new events, "abnormal bleeding (vaginal), yeast infection, dysmenorrhea (cramping), back pain, toe pain, forgetfulness, lower abdominal pain, brain fog, cutaneous candidiasis, vaginal irritation and pelvic infection" were added.Outcome of events, "dental issues, lower back and abdominal pain, forgetfulness, brain fog, fatigue" changed to "recovered/resolved".Outcome of events, "gluten intolerance, gastrointestinal issues, psoriasis" changed to "recovered/resolved".New reporter contact information was added.Patient's demographics were added.Lab data was added.Event abnormal periods clubbed with menorrhagia.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.
|
| |
|
Search Alerts/Recalls
|
|
