| Model Number ESS305 |
| Device Problems
Break (1069); Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Insufficient Information (3190)
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| Patient Problems
Pelvic Inflammatory Disease (2000); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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 device breakage ('essure found fragmented'), device dislocation ('essure found in wrong position in fallopian tube') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche, pregnancy and multiparous.In 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), device dislocation (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), pelvic pain ("sharp pelvic pain"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), menorrhagia ("heavy and prolonged menstruation with clots"), headache ("intense headaches"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), back pain ("lumbar pain"), feeling abnormal ("uterine perforation sensation"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), depression ("depression"), numbness of limbs ("numbness of upper limbs ") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, device dislocation, uterine inflammation, pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, body numbness, tremor, back pain, feeling abnormal, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, numbness of limbs and anxiety had not resolved.The reporter considered abdominal distension, adenomyosis, alopecia, anxiety, arthralgia, back pain, body numbness, breast pain, coital bleeding, depression, device breakage, device dislocation, dyspareunia, fatigue, feeling abnormal, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, tremor, uterine inflammation, vaginal discharge and numbness of limbs to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation were worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure found in wrong position in fallopian tube and fragmented.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and multiparous (4).In 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criterion medically significant), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), breast pain ("mastalgia"), abdominal distension ("distension"), oedema ("edema"), menorrhagia ("heavy and prolonged menstruation with clots"), headache ("intense headaches"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), back pain ("lumbar pain"), uterine pain ("uterine perforation sensation"), fatigue ("fatigue"), loss of libido ("loss of libido"), dyspareunia ("pain during and after sexual intercourse"), coital bleeding ("bleeding during and after sexual intercourse"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), depression ("depression"), numbness of limbs ("numbness of upper limbs ") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, breast pain, abdominal distension, oedema, menorrhagia, headache, pain in extremity, peripheral swelling, body numbness, tremor, back pain, uterine pain, fatigue, loss of libido, dyspareunia, coital bleeding, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, pain, vaginal discharge, depression, numbness of limbs and anxiety had not resolved.The reporter considered abdominal distension, adenomyosis, alopecia, anxiety, arthralgia, back pain, body numbness, breast pain, coital bleeding, depression, device breakage, device dislocation, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and numbness of limbs to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation were worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure found in wrong position in fallopian tube and fragmented.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: quality safety evaluation of ptc.After internal review, the event essure micro-insert found in wrong position in fallopian tube was downgraded to non serious incident.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity 4 (4).In 2014, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), back pain ("lumbar pain"), headache ("intense headaches"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), numbness of limbs ("numbness of upper limbs "), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, back pain, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression and anxiety had not resolved.The reporter considered abdominal distension, adenomyosis, alopecia, anxiety, arthralgia, back pain, body numbness, breast pain, coital bleeding, depression, device breakage, device dislocation, dyspareunia, fatigue, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, tremor, uterine inflammation, uterine pain, vaginal discharge and numbness of limbs to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on an unknown date: essure found in wrong position in fallopian tube and fragmented.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-jul-2020: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity 4 (4).In 2014, the patient had essure inserted.In 2017, the patient experienced headache ("intense headaches/ cephalea worsened"), numbness of limbs ("numbness of upper limbs"), abdominal pain lower ("pain like cramps in the lower abdomen"), polymenorrhagia ("menstrual flow and menstrual frequency increased with clots"), dysmenorrhoea ("intense pain during menstrual cycle"), diarrhoea ("sporadic intermittent diarrhea"), gastrointestinal motility disorder ("change of intestinal rhythm with water retention"), fluid retention ("change of intestinal rhythm with water retention") and vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), back pain ("lumbar pain"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, back pain, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression, anxiety, abdominal pain lower, polymenorrhagia, dysmenorrhoea, diarrhoea, gastrointestinal motility disorder, fluid retention and vulvovaginal pruritus had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, fluid retention, gastrointestinal motility disorder, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, numbness of limbs, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine inflammation, uterine pain, vaginal discharge, vulvovaginal pruritus and body numbness to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on (b)(6) 2020: essure found in wrong position in fallopian tube and fragmented.Essure can perforate the internal organs.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-sep-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity 4 (4).In 2014, the patient had essure inserted.In 2017, the patient experienced headache ("intense headaches/ cephalea worsened"), numbness of limbs ("numbness of upper limbs"), abdominal pain lower ("pain like cramps in the lower abdomen"), polymenorrhagia ("menstrual flow and menstrual frequency increased with clots"), dysmenorrhoea ("intense pain during menstrual cycle"), diarrhoea ("sporadic intermittent diarrhea"), gastrointestinal motility disorder ("change of intestinal rhythm with water retention"), fluid retention ("change of intestinal rhythm with water retention") and vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), back pain ("lumbar pain"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, back pain, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression, anxiety, abdominal pain lower, polymenorrhagia, dysmenorrhoea, diarrhoea, gastrointestinal motility disorder, fluid retention and vulvovaginal pruritus had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, fluid retention, gastrointestinal motility disorder, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, numbness of limbs, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine inflammation, uterine pain, vaginal discharge, vulvovaginal pruritus and body numbness to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on (b)(6) 2020: essure found in wrong position in fallopian tube and fragmented.Essure can perforate the internal organs.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11 quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: new events menstrual flow and menstrual frequency increased with clots, pain like cramps in the lower abdomen, intense pain during menstrual cycle, sporadic intermittent diarrhea, change of intestinal rhythm with water retention, vaginal pruritus were added.The event term intense headaches was changed to intense headaches/ cephalea worsened.Start date of events numbness of upper limbs and intense headaches/ cephalea worsened was added.Lab data was updated.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity 4 (4).In 2014, the patient had essure inserted.In 2017, the patient experienced headache ("intense headaches/ cephalea worsened"), numbness of limbs ("numbness of upper limbs"), abdominal pain lower ("pain like cramps in the lower abdomen"), polymenorrhagia ("menstrual flow and menstrual frequency increased with clots"), dysmenorrhoea ("intense pain during menstrual cycle"), diarrhoea ("sporadic intermittent diarrhea"), gastrointestinal motility disorder ("change of intestinal rhythm with water retention"), fluid retention ("change of intestinal rhythm with water retention") and vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), back pain ("lumbar pain"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression") and anxiety ("anxiety").The patient was treated with analgesics and antiinflammatory agents.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, back pain, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression, anxiety, abdominal pain lower, polymenorrhagia, dysmenorrhoea, diarrhoea, gastrointestinal motility disorder, fluid retention and vulvovaginal pruritus had not resolved.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, back pain, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, fatigue, fluid retention, gastrointestinal motility disorder, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, numbness of limbs, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine inflammation, uterine pain, vaginal discharge, vulvovaginal pruritus and body numbness to be related to essure.The reporter commented: headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray - on (b)(6) 2020: essure found in wrong position in fallopian tube and fragmented.Essure can perforate the internal organs.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-sep-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity 4 (4).In (b)(6) 2012, the patient had essure inserted.In 2017, the patient experienced headache ("intense headaches/ cephalea worsened"), numbness of limbs ("numbness of upper limbs"), abdominal pain lower ("pain like cramps in the lower abdomen"), polymenorrhagia ("menstrual flow and menstrual frequency increased with clots"), dysmenorrhoea ("intense pain during menstrual cycle"), diarrhoea ("sporadic intermittent diarrhea"), gastrointestinal motility disorder ("change of intestinal rhythm with water retention"), fluid retention ("change of intestinal rhythm with water retention") and vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), the first episode of back pain ("lumbar pain"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression"), anxiety ("anxiety"), nausea ("nausea"), cramp in lower abdomen ("cramping"), the second episode of back pain ("lumbar pain"), uterine haemorrhage ("abnormal uterine bleeding"), uterine polyp ("endometrial polyp"), endometriosis ("endometriosis") and blood loss anaemia ("anemia (due to frequent menstrual bleeding)").The patient was treated with analgesics, antiinflammatory agents, ferrous sulfate (iron sulfate) and oral contraceptive nos.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression, anxiety, abdominal pain lower, polymenorrhagia, dysmenorrhoea, diarrhoea, gastrointestinal motility disorder, fluid retention and vulvovaginal pruritus had not resolved and the nausea, cramp in lower abdomen, the last episode of back pain, uterine haemorrhage, uterine polyp, endometriosis and blood loss anaemia outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, blood loss anaemia, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fatigue, fluid retention, gastrointestinal motility disorder, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, nausea, numbness of limbs, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine haemorrhage, uterine inflammation, uterine pain, uterine polyp, vaginal discharge, vulvovaginal pruritus, the first episode of back pain, body numbness, cramp in lower abdomen and the second episode of back pain to be related to essure.The reporter commented: insertion date also reported as 2013 and 2014.Headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): magnetic resonance imaging - on (b)(6) 2021: essure seen bilaterally.Ultrasound scan - in (b)(6) 2020: adenomyosis.X-ray - on (b)(6) 2020: essure found in wrong position in fallopian tube and fragmented.Essure can perforate the internal organs.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-mar-2021: insertion date updated.Reporter, lab data, treatment drugs and events náusea, cramping, lumbar pain, abnormal uterine bleeding, endometrial polyp, endometriosis, anemia (due to frequent menstrual bleeding) added.We received a lot number in this case.A technical investigation was 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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure found fragmented') and uterine inflammation ('uterine inflammation') in an adult female patient who had essure (batch no.925785) inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included menarche (13 years old), multigravida (5) and parity (4).In (b)(6) 2012, the patient had essure inserted.In 2017, the patient experienced headache ("intense headaches/ cephalea worsened"), numbness of limbs ("numbness of upper limbs"), abdominal pain lower ("pain like cramps in the lower abdomen"), polymenorrhagia ("menstrual flow and menstrual frequency increased with clots"), dysmenorrhoea ("intense pain during menstrual cycle"), diarrhoea ("sporadic intermittent diarrhea"), gastrointestinal motility disorder ("change of intestinal rhythm with water retention"), fluid retention ("change of intestinal rhythm with water retention") and vulvovaginal pruritus ("vaginal pruritus").On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), uterine inflammation (seriousness criteria medically significant and intervention required), device dislocation ("essure found in wrong position in fallopian tube"), pelvic pain ("sharp pelvic pain"), uterine pain ("uterine perforation sensation"), dyspareunia ("pain during and after sexual intercourse"), menorrhagia ("heavy and prolonged menstruation with clots"), abdominal distension ("distension"), the first episode of back pain ("lumbar pain"), pain ("generalized body pain"), vaginal discharge ("vaginal discharge with odor"), breast pain ("mastalgia"), coital bleeding ("bleeding during and after sexual intercourse"), oedema ("edema"), pain in extremity ("pain in legs"), peripheral swelling ("swelling in legs"), body numbness ("body numbness"), tremor ("tremor"), fatigue ("fatigue"), loss of libido ("loss of libido"), arthralgia ("joint pain"), mood altered ("mood changes"), alopecia ("hair loss"), adenomyosis ("suspicion of adenomyosis"), intra-abdominal fluid collection ("abdominal fluid retention"), depression ("depression"), anxiety ("anxiety"), nausea ("nausea"), cramp in lower abdomen ("cramping"), the second episode of back pain ("lumbar pain"), uterine haemorrhage ("abnormal uterine bleeding"), uterine polyp ("endometrial polyp"), endometriosis ("endometriosis") and blood loss anaemia ("anemia (due to frequent menstrual bleeding)").The patient was treated with analgesics, antiinflammatory agents, ferrous sulfate (iron sulfate) and oral contraceptive nos.Essure treatment was not changed.At the time of the report, the device breakage, uterine inflammation, device dislocation, pelvic pain, uterine pain, dyspareunia, menorrhagia, abdominal distension, headache, pain, vaginal discharge, breast pain, coital bleeding, oedema, pain in extremity, peripheral swelling, body numbness, numbness of limbs, tremor, fatigue, loss of libido, arthralgia, mood altered, alopecia, adenomyosis, intra-abdominal fluid collection, depression, anxiety, abdominal pain lower, polymenorrhagia, dysmenorrhoea, diarrhoea, gastrointestinal motility disorder, fluid retention and vulvovaginal pruritus had not resolved and the nausea, cramp in lower abdomen, the last episode of back pain, uterine haemorrhage, uterine polyp, endometriosis and blood loss anaemia outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, adenomyosis, alopecia, anxiety, arthralgia, blood loss anaemia, breast pain, coital bleeding, depression, device breakage, device dislocation, diarrhoea, dysmenorrhoea, dyspareunia, endometriosis, fatigue, fluid retention, gastrointestinal motility disorder, headache, intra-abdominal fluid collection, loss of libido, menorrhagia, mood altered, nausea, numbness of limbs, oedema, pain, pain in extremity, pelvic pain, peripheral swelling, polymenorrhagia, tremor, uterine haemorrhage, uterine inflammation, uterine pain, uterine polyp, vaginal discharge, vulvovaginal pruritus, the first episode of back pain, body numbness, cramp in lower abdomen and the second episode of back pain to be related to essure.The reporter commented: insertion date also reported as 2013 and 2014.Headache, numbness of upper limbs and heavy and prolonged menstruation worsened in 2017.Diagnostic results (normal ranges are provided in parenthesis if available): magnetic resonance imaging - on (b)(6) 2021: essure seen bilaterally.Ultrasound scan - in (b)(6) 2020: adenomyosis.X-ray - on (b)(6) 2020: essure found in wrong position in fallopian tube and fragmented.Essure can perforate the internal organs.Lot number 925785, manufacturing date: 2011/11, expiration date: 2014/11.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.Most recent follow-up information incorporated above includes: on (b)(6) 2021: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was 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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