| Model Number ESS305 |
| Device Problems
Break (1069); Biocompatibility (2886); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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| Patient Problems
Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Tissue Breakdown (2681); Device Embedded In Tissue or Plaque (3165); Genital Bleeding (4507)
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| Event Date 04/08/2019 |
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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 genital haemorrhage ('excessive bleeding') and allergy to metals ('allergies, epicutaneous test positive for delayed hypersensitivity to nickel') in a (b)(6)-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 2 and multigravida.Concurrent conditions included allergic reaction to analgesics.Concomitant products included ibuprofen.In (b)(6) 2016, the patient had essure inserted.In (b)(6) 2019, the patient experienced procedural pain ("in the days after removal procedure, a lot of abdominal pain") with post procedural discomfort, urinary incontinence ("in the days after removal procedure, urinary incontinence"), post procedural constipation ("in the days after removal procedure, not being able to defecate for some days") with flatulence and procedural dizziness ("after removal procedure, feeling dizzy after getting up").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria hospitalization and intervention required), allergy to metals (seriousness criteria hospitalization and intervention required) with device intolerance, pelvic pain ("pelvic pain"), back pain ("back pain"), headache ("headaches"), swelling ("swelling"), arthralgia ("joint pain / hip pain"), fatigue ("excessive tiredness"), alopecia ("hair loss"), pain ("physical pain"), skin lesion ("occasional skin lesion") and dermatitis contact ("contact dermatitis") and was found to have weight increased ("weight gain").The patient was hospitalized from (b)(6) 2019.The patient was treated with alprazolam, mometasone furoate (elocom), ranitidine and surgery (subtotal hysterectomy + bilateral salpingectomy).Essure was removed on (b)(6) 2019.At the time of the report, the genital haemorrhage, allergy to metals, pelvic pain, procedural pain, back pain, headache, arthralgia, fatigue, alopecia, weight increased, skin lesion and dermatitis contact outcome was unknown and the urinary incontinence, post procedural constipation and procedural dizziness had resolved.The reporter considered allergy to metals, alopecia, arthralgia, back pain, dermatitis contact, fatigue, genital haemorrhage, headache, pain, pelvic pain, post procedural constipation, procedural dizziness, procedural pain, skin lesion, swelling, urinary incontinence and weight increased to be related to essure.The reporter commented: menstrual cycle: (b)(6) surgery (b)(6) 2019: laparoscopy: subtotal hysterectomy + bilateral salpingectomy including essure devices.1st stage: laparoscopy: bilateral salpingectomy with removal of the essure devices.Radiological control: essure fragment still remains in right uterine horn.2nd stage: surgery was completed as agreed with the patient.Subtotal hysterectomy by laparoscopy.Subsequent radiological control: it was observed that there was a metal fragment in the portion extracted during the hysterectomy.The patient's pelvis was clear.Post-operation: afebrile.The patient evolved favourably.Pre-discharge examination: abdomen soft and depressible, clean wounds, superficial pain on palpation in fii (secondary to fascia suture), healthy looking cervix, little bleeding from cervical canal.Medical history of body systems: good general status.(b)(6) heart association classification i.Physical examination.Airway examination.Mallampati: 1; oral aperture: good; mobile dental prosthesis: no; thyromental distance: >3td; cervical mobility: preserved; previous cormack surgical pre-operative: biochemical: no significant alterations.Haemogram: no significant alterations.Coagulation: without significant alterations.Blood pressure (mm.Hg.) 120/90 heart rate.(beats/minute) 0 temperature (celsius) 0 weight (kg.) (b)(6) height (cm) 156 respiratory rate(breath/min.) 0 diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Skin test - on an unknown date: epicutaneous patch test for the diagnosis of delayed hypersensitivity: positive to nickel, quinolines and caine mix.Ultrasound scan vagina - on an unknown date: uterus in anteversion with endometrium of 6.8 mm.Normal left ovary.Right ovary with functional formation of 2.7 cm.Both essure devices are observed, but the part inside the myometrium on the left one cannot be observed.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 genital haemorrhage ('excessive bleeding'), device breakage ('after first stage of surgery, essure fragment still remains in right uterine horn') and allergy to metals ('allergies, epicutaneous test positive for delayed hypersensitivity to nickel') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 2 and multigravida.Concurrent conditions included allergic reaction to analgesics.Concomitant products included ibuprofen.In (b)(6) 2016, the patient had essure inserted.On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal").In (b)(6) 2019, the patient experienced procedural pain ("in the days after removal procedure, a lot of abdominal pain") with post procedural discomfort, urinary incontinence ("in the days after removal procedure, urinary incontinence"), post procedural constipation ("in the days after removal procedure, not being able to defecate for some days") with flatulence and procedural dizziness ("after removal procedure, feeling dizzy after getting up").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria hospitalization and intervention required), allergy to metals (seriousness criteria hospitalization and intervention required) with device intolerance, pelvic pain ("pelvic pain"), back pain ("back pain"), headache ("headaches"), swelling ("swelling"), arthralgia ("joint pain / hip pain"), fatigue ("excessive tiredness"), alopecia ("hair loss"), pain ("physical pain"), skin lesion ("occasional skin lesion") and dermatitis contact ("contact dermatitis") and was found to have weight increased ("weight gain").The patient was hospitalized from (b)(6) 2019.The patient was treated with alprazolam, mometasone furoate (elocom), ranitidine and surgery (subtotal hysterectomy and subtotal hysterectomy + bilateral salpingectomy).Essure was removed on (b)(6) 2019.On (b)(6) 2019, the device breakage and complication of device removal had resolved.At the time of the report, the genital haemorrhage, allergy to metals, pelvic pain, procedural pain, back pain, headache, swelling, arthralgia, fatigue, alopecia, weight increased, skin lesion and dermatitis contact outcome was unknown and the urinary incontinence, post procedural constipation and procedural dizziness had resolved.The reporter considered allergy to metals, alopecia, arthralgia, back pain, complication of device removal, dermatitis contact, device breakage, fatigue, genital haemorrhage, headache, pain, pelvic pain, post procedural constipation, procedural dizziness, procedural pain, skin lesion, swelling, urinary incontinence and weight increased to be related to essure.The reporter commented: menstrual cycle: (b)(6).Surgery.On (b)(6) 2019: laparoscopy: subtotal hysterectomy + bilateral salpingectomy including essure devices.1st stage: laparoscopy: bilateral salpingectomy with removal of the essure devices.Radiological control: essure fragment still remains in right uterine horn.2nd stage: surgery was completed as agreed with the patient.Subtotal hysterectomy by laparoscopy.Subsequent radiological control: it was observed that there was a metal fragment in the portion extracted during the hysterectomy.The patient's pelvis was clear.Post-operation: afebrile.The patient evolved favourably.Pre-discharge examination: abdomen soft and depressible, clean wounds, superficial pain on palpation in fii (secondary to fascia suture), healthy looking cervix, little bleeding from cervical canal.Medical history of body systems, good general status, new york heart association classification i, physical examination, airway examination.Mallampati: 1; oral aperture: good; mobile dental prosthesis: no; thyromental distance: >3td; cervical.Mobility: preserved; previous cormack surgical.Pre-operative: biochemical: no significant alterations.Haemogram: no significant alterations.Coagulation: without significant alterations.Blood pressure (mm.Hg.) 120/90 heart rate.(beats/minute) 0 temperature (celsius) 0.Weight (kg.) 63 height (cm) 156 respiratory rate(breath/min.) 0.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Skin test - on an unknown date: epicutaneous patch test for the diagnosis of delayed hypersensitivity: positive to nickel, quinolines and caine mix.Ultrasound scan vagina - on an unknown date: uterus in anteversion with endometrium of 6.8 mm.Normal left ovary.Right ovary with functional formation of 2.7 cm.Both essure devices are observed, but the part inside the myometrium on the left one cannot be observed.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.Following company internal review, events 'device breakage' and 'complication of device removal' were extracted.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 genital haemorrhage ('excessive bleeding'), device breakage ('after first stage of surgery, essure fragment still remains in right uterine horn') and allergy to metals ('allergies, epicutaneous test positive for delayed hypersensitivity to nickel') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's medical history included parity 2 and multigravida.Concurrent conditions included allergic reaction to analgesics.Concomitant products included ibuprofen.In (b)(6) 2016, the patient had essure inserted.On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and complication of device removal ("complication of device removal").In (b)(6) 2019, the patient experienced procedural pain ("in the days after removal procedure, a lot of abdominal pain") with post procedural discomfort, urinary incontinence ("in the days after removal procedure, urinary incontinence"), post procedural constipation ("in the days after removal procedure, not being able to defecate for some days") with flatulence and procedural dizziness ("after removal procedure, feeling dizzy after getting up").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria hospitalization and intervention required), allergy to metals (seriousness criteria hospitalization and intervention required) with device intolerance, pelvic pain ("pelvic pain"), back pain ("back pain"), headache ("headaches"), swelling ("swelling"), arthralgia ("joint pain / hip pain"), fatigue ("excessive tiredness"), alopecia ("hair loss"), pain ("physical pain"), skin lesion ("occasional skin lesion") and dermatitis contact ("contact dermatitis") and was found to have weight increased ("weight gain").The patient was hospitalized from (b)(6) 2019.The patient was treated with alprazolam, mometasone furoate (elocom), ranitidine and surgery (subtotal hysterectomy and subtotal hysterectomy + bilateral salpingectomy).Essure was removed on (b)(6) 2019.On (b)(6) 2019, the device breakage and complication of device removal had resolved.At the time of the report, the genital haemorrhage, allergy to metals, pelvic pain, procedural pain, back pain, headache, swelling, arthralgia, fatigue, alopecia, pain, weight increased, skin lesion and dermatitis contact outcome was unknown and the urinary incontinence, post procedural constipation and procedural dizziness had resolved.The reporter considered allergy to metals, alopecia, arthralgia, back pain, complication of device removal, dermatitis contact, device breakage, fatigue, genital haemorrhage, headache, pain, pelvic pain, post procedural constipation, procedural dizziness, procedural pain, skin lesion, swelling, urinary incontinence and weight increased to be related to essure.No further causality assessment were provided for the product.The reporter commented: menstrual cycle: (b)(6).Surgery: (b)(6) 2019: laparoscopy: subtotal hysterectomy + bilateral salpingectomy including essure devices.1st stage: laparoscopy: bilateral salpingectomy with removal of the essure devices.Radiological control: essure fragment still remains in right uterine horn.2nd stage: surgery was completed as agreed with the patient.Subtotal hysterectomy by laparoscopy.Subsequent radiological control: it was observed that there was a metal fragment in the portion extracted during the hysterectomy.The patient's pelvis was clear.Post-operation: afebrile.The patient evolved favourably.Pre-discharge examination: abdomen soft and depressible, clean wounds, superficial pain on palpation in fii (secondary to fascia suture), healthy looking cervix, little bleeding from cervical canal.Medical history of body systems.Good general status.New york heart association classification i.Physical examination.Airway examination.Mallampati: 1; oral aperture: good; mobile dental prosthesis: no; thyromental distance: >3td; cervical.Mobility: preserved; previous cormack surgical.Pre-operative: biochemical: no significant alterations.Haemogram: no significant alterations.Coagulation: without significant alterations.Blood pressure (mm.Hg.) 120/90 heart rate.(beats/minute) 0 temperature (celsius) 0.Weight (kg.) 63 height (cm) 156 respiratory rate(breath/min.) 0.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Skin test - on an unknown date: epicutaneous patch test for the diagnosis of delayed.Hypersensitivity: positive to nickel, quinolines and caine mix.Ultrasound scan vagina on an unknown date: uterus in anteversion with endometrium of 6.8 mm.Normal left ovary.Right ovary with functional formation of 2.7 cm.Both essure devices are observed, but the part inside the myometrium on the left one cannot be observed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 5-aug-2020: quality safety evaluation of ptc.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 genital haemorrhage ('excessive bleeding'), device breakage ('after first stage of surgery, essure fragment still remains in right uterine horn') and allergy to metals ('allergies, epicutaneous test positive for delayed hypersensitivity to nickel') in a 39-year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: complication of device removal "complication of device removal" on (b)(6) 2019.The patient's medical history included parity 2 and multigravida.Concurrent conditions included allergic reaction to analgesics.Concomitant products included ibuprofen.In (b)(6) 2016, the patient had essure inserted.On (b)(6) 2019, the patient experienced device breakage (seriousness criteria medically significant and intervention required).In (b)(6) 2019, the patient experienced procedural pain ("in the days after removal procedure, a lot of abdominal pain") with post procedural discomfort, urinary incontinence ("in the days after removal procedure, urinary incontinence"), post procedural constipation ("in the days after removal procedure, not being able to defecate for some days") with flatulence and procedural dizziness ("after removal procedure, feeling dizzy after getting up").On an unknown date, the patient experienced genital haemorrhage (seriousness criteria hospitalization and intervention required), allergy to metals (seriousness criteria hospitalization and intervention required) with device intolerance, pelvic pain ("pelvic pain"), back pain ("back pain"), headache ("headaches"), swelling ("swelling"), arthralgia ("joint pain / hip pain"), fatigue ("excessive tiredness"), alopecia ("hair loss"), pain ("physical pain"), skin lesion ("occasional skin lesion"), dermatitis contact ("contact dermatitis"), hypersensitivity ("allergic reaction") and insomnia ("excessive insomnia") and was found to have weight increased ("weight gain").The patient was hospitalized from (b)(6) 2019 to (b)(6) 2019.The patient was treated with alprazolam, mometasone furoate (elocom), ranitidine and surgery (subtotal hysterectomy and subtotal hysterectomy + bilateral salpingectomy).Essure was removed on (b)(6) 2019.On (b)(6) 2019, the device breakage had resolved.At the time of the report, the genital haemorrhage, allergy to metals, pelvic pain, procedural pain, back pain, headache, swelling, arthralgia, fatigue, alopecia, pain, weight increased, skin lesion and dermatitis contact outcome was unknown and the urinary incontinence, post procedural constipation and procedural dizziness had resolved.The reporter considered allergy to metals, alopecia, arthralgia, back pain, dermatitis contact, device breakage, fatigue, genital haemorrhage, headache, hypersensitivity, insomnia, pain, pelvic pain, post procedural constipation, procedural dizziness, procedural pain, skin lesion, swelling, urinary incontinence and weight increased to be related to essure.The reporter commented: menstrual cycle: (b)(6) surgery: (b)(6) 2019: laparoscopy: subtotal hysterectomy + bilateral salpingectomy including essure devices.1st stage: laparoscopy: bilateral salpingectomy with removal of the essure devices.Radiological control: essure fragment still remains in right uterine horn.2nd stage: surgery was completed as agreed with the patient.Subtotal hysterectomy by laparoscopy.Subsequent radiological control: it was observed that there was a metal fragment in the portion extracted during the hysterectomy.The patient's pelvis was clear.Post-operation: afebrile.The patient evolved favourably.Pre-discharge examination: abdomen soft and depressible, clean wounds, superficial pain on palpation in fii (secondary to fascia suture), healthy looking cervix, little bleeding from cervical canal.Medical history of body systems: good general status; new york heart association classification i; physical examination; airway examination; mallampati: 1; oral aperture: good; mobile dental prosthesis: no; thyromental distance: >3td; cervical; mobility: preserved; previous cormack surgical.Pre-operative: biochemical: no significant alterations; haemogram: no significant alterations; coagulation: without significant alterations.Blood pressure (mm.Hg.) 120/90 heart rate.(beats/minute) 0 temperature (celsius) 0 weight (kg.) 63 height (cm) 156 respiratory rate(breath/min.) 0.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 25.9 kg/sqm.Skin test - on an unknown date: epicutaneous patch test for the diagnosis of delayed hypersensitivity: positive to nickel, quinolines and caine mix.Ultrasound scan vagina - on an unknown date: uterus in anteversion with endometrium of 6.8 mm.Normal left ovary.Right ovary with functional formation of 2.7 cm.Both essure devices are observed, but the part inside the myometrium on the left one cannot be observed.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-jun-2022: reporter details and events allergic reaction and excessive insomnia added.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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