| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Anemia (1706); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Fever (1858); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Pelvic Inflammatory Disease (2000); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Anxiety (2328); Depression (2361); Reaction (2414); Numbness (2415); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Constipation (3274)
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| Event Date 02/01/2008 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pelvic inflammatory disease"), pelvic pain ("severe pelvic pain") and genital haemorrhage ("abnormal bleeding") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, difficulty breathing, asthma aggravated, allergic rhinitis, vitamin deficiency nos, multiple allergies and allergic reaction to antibiotics.Concomitant products included panadeine co (tylenol #3) for abdominal pain, leg pain, pelvic pain, migraine and headache, diclofenac sodium (diclofenac al) and naproxen since 2008 for back pain, colecalciferol (vitamin d) and cyanocobalamin (vitamin b12) for fatigue as well as calcium ferrous citrate (ferrocal), salbutamol (albuterol) since 2008 and steroid antibacterials.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("depression") and anxiety ("anxiety").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criterion medically significant), abdominal pain ("abdominal pain") and pain in extremity ("leg pain").In (b)(6) 2008, the patient experienced migraine ("migraines") and nausea ("nausea").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In (b)(6) 2009, the patient experienced urinary tract infection ("uti").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In 2009, the patient experienced anaemia ("anemia").In (b)(6) 2009, the patient experienced weight decreased ("weight loss").In (b)(6) 2016, the patient experienced back pain ("back pain").In (b)(6) 2016, the patient experienced headache ("headaches").In (b)(6) 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("severe lower abdominal pain") and constipation ("constipation").Essure treatment was not changed.At the time of the report, the pelvic inflammatory disease, back pain, abdominal pain, pain in extremity, vaginal haemorrhage, menorrhagia, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, dysmenorrhoea, nausea, depression, anxiety and constipation outcome was unknown and the pelvic pain, genital haemorrhage, dyspareunia, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anaemia, anxiety, back pain, constipation, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection and weight decreased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.Most recent follow-up information incorporated above includes: on 7-jun-2018: plaintiff fact sheet and medical records received.Events added from pfs- abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), heavy menstrual cycle, abdominal pain, leg pain, back pain, hair loss, anemia, bloating, leg numbness, weight gain, weight loss, dysmenorrhea.Concomitant disease 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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Manufacturer Narrative
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The spontaneous case was reported by a lawyer and describes the occurrence of pelvic inflammatory disease ("pelvic inflammatory disease"), pelvic pain ("severe pelvic pain") and genital haemorrhage ("abnormal bleeding") in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's previously administered products included for heavy periods: ortho-novum from (b)(6) 2016 to (b)(6) 2016; for birth-control: depo-provera from (b)(6) to (b)(6).Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, asthma, allergic rhinitis, vitamin deficiency, penicillin allergy, allergic reaction to antibiotics and upper respiratory infection.Concomitant products included panadiene co (tylenol #3) for abdominal pain, leg pain, pelvic pain, migraine and headache, diclofenac sodium (diclofenac al) and naproxen since (b)(6) for back pain, cholecalciferol (vitamin d) and cyanocobalamin (vitamin b12) for fatigue as well as salbutamol (albuterol) since (b)(6).On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression") and anxiety ("psychological or psychiatric problems condition: anxiety").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criterion medically significant), abdominal pain ("abdominal pain") and pain in extremity ("leg pain").In (b)(6) 2008, the patient experienced migraine ("migraines") and nausea ("nausea").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In (b)(6) 2009, the patient experienced urinary tract infection ("bladder or urinary problems or changes: uti").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) , the patient experienced anaemia ("anemia").In (b)(6) 2009, the patient experienced weight decreased ("weight loss").In (b)(6) 2016, the patient experienced back pain ("back pain").In (b)(6) 2016, the patient experienced headache ("headaches").In (b)(6) 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("severe lower abdominal pain"), constipation ("constipation") and muscle spasms ("leg cramping").The patient was treated with steroid antibacterials and calcium ferrous citrate (ferrocal).Essure treatment was not changed.At the time of the report, the pelvic inflammatory disease, back pain, abdominal pain, pain in extremity, vaginal haemorrhage, menorrhagia, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, dysmenorrhoea, nausea, depression, anxiety, constipation and muscle spasms outcome was unknown and the pelvic pain, genital haemorrhage, dyspareunia, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anaemia, anxiety, back pain, constipation, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, muscle spasms, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection and weight decreased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.Most recent follow-up information incorporated above includes: on 19-jun-2018: plaintiff fact sheet received.Historical drug added.Event added: plaintiff did not undergo essure confirmation test and leg cramping.Incident: no lot number or sample available for investigation.There is no evidence that a device related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('severe pelvic pain'), pelvic inflammatory disease ('pelvic inflammatory disease') and genital haemorrhage ('abnormal bleeding/ bleeding/ plaintiff claiming bleeding: other') in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's previously administered products included for heavy periods: ortho-novum from 12-may-2016 to 12-jun-2016; for birth-control: depo-provera from 2002 to 2005.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, asthma, allergic rhinitis, vitamin deficiency, penicillin allergy, allergic reaction to antibiotics and upper respiratory infection.Concomitant products included codeine phosphate;paracetamol (tylenol with codeine no.3) for abdominal pain, leg pain, pelvic pain, migraine and headache, diclofenac sodium (diclofenac al) and naproxen since 2008 for back pain, cyanocobalamin and vitamin d nos (vitamin d) for fatigue as well as salbutamol (albuterol) since 2008.On (b)(6) 2008, the patient had essure inserted.In february 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression/psych injury") and anxiety ("psychological or psychiatric problems condition: anxiety/psych injury").In march 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and pain in extremity ("leg pain").In april 2008, the patient experienced migraine ("migraines") and nausea ("nausea").In december 2008, the patient experienced alopecia ("hair loss").In february 2009, the patient experienced urinary tract infection ("bladder or urinary problems or changes: uti").In may 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In 2009, the patient experienced anaemia ("anemia").In november 2009, the patient was found to have weight decreased ("weight loss").In january 2016, the patient experienced back pain ("back pain").In april 2016, the patient experienced headache ("headaches").In may 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("severe lower abdominal pain"), constipation ("constipation/ other injuries/symptoms : gi conditions"), muscle spasms ("leg cramping"), rash ("allergy: rash/skin condition") and skin disorder ("skin condition") and was found to have weight increased ("other injuries/symptoms : weight gain").The patient was treated with ferrous sulfate (ferrousul), steroid antibacterials and surgery (full hysterectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved, the pelvic inflammatory disease, abdominal pain, pain in extremity, vaginal haemorrhage, menorrhagia, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, nausea, depression, anxiety, constipation, muscle spasms and weight increased outcome was unknown and the genital haemorrhage, back pain, dyspareunia, dysmenorrhoea, rash and skin disorder had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anaemia, anxiety, back pain, constipation, depression, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, muscle spasms, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, rash, skin disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, weight decreased and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.Most recent follow-up information incorporated above includes: on 11-sep-2019: new pfs received- new events added: allergy: rash/skin condition, other injuries/symptoms : weight gain.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 pelvic pain ('severe pelvic pain') and pelvic inflammatory disease ('pelvic inflammatory disease') in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's previously administered products included for heavy periods: ortho-novum from (b)(6) 2016; for birth-control: depo-provera from 2002 to 2005.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, asthma, allergic rhinitis, vitamin deficiency, penicillin allergy, allergic reaction to antibiotics and upper respiratory infection.Concomitant products included codeine phosphate;paracetamol (tylenol with codeine no.3) for abdominal pain, leg pain, pelvic pain, migraine and headache, diclofenac sodium (diclofenac al) and naproxen since 2008 for back pain, cyanocobalamin and vitamin d nos (vitamin d) for fatigue as well as salbutamol (albuterol) since 2008.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced anaemia ("anemia/ blood or heart disorder/condition type: anemia").In (b)(6) 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression/psych injury") and anxiety ("psychological or psychiatric problems condition: anxiety/psych injury").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and pain in extremity ("leg pain/ left leg pain").In (b)(6) 2008, the patient experienced migraine ("migraines"), nausea ("nausea"), vulvovaginal mycotic infection ("infection (other) describe: yeast") and eczema ("eczema").In (b)(6) 2008, the patient experienced back pain ("back pain/ pain lower back").In (b)(6) 2008, the patient was found to have weight increased ("other injuries/symptoms : weight gain").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In (b)(6) 2009, the patient experienced urinary tract infection ("bladder or urinary problems or changes: uti").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2009, the patient was found to have weight decreased ("weight loss").In (b)(6) 2016, the patient experienced headache ("headaches").In (b)(6) 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage ("abnormal bleeding/ bleeding/ plaintiff claiming bleeding: other"), abdominal pain lower ("severe lower abdominal pain"), constipation ("constipation/ other injuries/symptoms : gi conditions"), muscle spasms ("leg cramping"), dermatitis allergic ("allergy: rash/skin condition") and skin disorder ("skin condition").The patient was treated with ferrous sulfate (ferrousul), steroid antibacterials and surgery (full hysterectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved, the pelvic inflammatory disease, abdominal pain, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, nausea, depression, anxiety, constipation, muscle spasms, weight increased and vulvovaginal mycotic infection outcome was unknown and the genital haemorrhage, back pain, pain in extremity, dyspareunia, vaginal haemorrhage, menorrhagia, dysmenorrhoea, dermatitis allergic, skin disorder and eczema had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anaemia, anxiety, back pain, constipation, depression, dermatitis allergic, dysmenorrhoea, dyspareunia, eczema, fatigue, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, muscle spasms, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, skin disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.Most recent follow-up information incorporated above includes: on 6-feb-2020: plaintiff fact sheet received : reporter added.Events added- vulvovaginal mycotic infection, eczema.Severity of ¿pain in extremity¿ and ¿back pain¿ updated.Event of genital haemorrhage updated to non-serious from medically significant.Outcome of events ¿vaginal haemorrhage, menorrhagia, pain in extremity, eczema¿ updated to ¿recovered / resolved¿.Onset date of the events updated and added.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 pelvic pain ('severe pelvic pain') and pelvic inflammatory disease ('pelvic inflammatory disease') in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's previously administered products included for heavy periods: ortho-novum from (b)(6) 2016 to (b)(6) 2016; for birth-control: depo-provera from 2002 to 2005.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, asthma, allergic rhinitis, vitamin deficiency, penicillin allergy, allergic reaction to antibiotics and upper respiratory infection.Concomitant products included codeine phosphate;paracetamol (tylenol with codeine no.3) for abdominal pain, leg pain, pelvic pain, migraine and headache, diclofenac sodium (diclofenac al) and naproxen since 2008 for back pain, cyanocobalamin and vitamin d nos (vitamin d) for fatigue as well as salbutamol (albuterol) since 2008.On (b)(6) 2008, the patient had essure inserted.In (b)(6) 2008, the patient experienced anaemia ("anemia/ blood or heart disorder/condition type: anemia").In (b)(6) 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression/psych injury") and anxiety ("psychological or psychiatric problems condition: anxiety/psych injury").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and pain in extremity ("leg pain/ left leg pain").In (b)(6) 2008, the patient experienced migraine ("migraines"), nausea ("nausea"), vulvovaginal mycotic infection ("infection (other) describe: yeast") and eczema ("eczema").In (b)(6) 2008, the patient experienced back pain ("back pain/ pain lower back").In (b)(6) 2008, the patient was found to have weight increased ("other injuries/symptoms : weight gain").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In (b)(6) 2009, the patient experienced urinary tract infection ("bladder or urinary problems or changes: uti").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2009, the patient was found to have weight decreased ("weight loss").In (b)(6) 2016, the patient experienced headache ("headaches").In (b)(6) 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage ("abnormal bleeding/ bleeding/ plaintiff claiming bleeding: other"), abdominal pain lower ("severe lower abdominal pain"), constipation ("constipation/ other injuries/symptoms : gi conditions"), muscle spasms ("leg cramping"), dermatitis allergic ("allergy: rash/skin condition") and skin disorder ("skin condition").The patient was treated with ferrous sulfate (ferrousul), steroid antibacterials and surgery (full hysterectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved, the pelvic inflammatory disease, abdominal pain, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, nausea, depression, anxiety, constipation, muscle spasms, weight increased and vulvovaginal mycotic infection outcome was unknown and the genital haemorrhage, back pain, pain in extremity, dyspareunia, vaginal haemorrhage, menorrhagia, dysmenorrhoea, dermatitis allergic, skin disorder and eczema had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, alopecia, anaemia, anxiety, back pain, constipation, depression, dermatitis allergic, dysmenorrhoea, dyspareunia, eczema, fatigue, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, muscle spasms, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, skin disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.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 product technical complaint.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 pelvic pain ('severe pelvic pain') and pelvic inflammatory disease ('pelvic inflammatory disease') in a 25-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "plaintiff did not undergo essure confirmation test".The patient's previously administered products included for heavy periods: ortho-novum from (b)(6) 2016 to (b)(6) 2016; for birth-control: depo-provera from 2002 to 2005.Past adverse reactions to the above products included pregnancy with depo-provera.Concurrent conditions included body mass index normal, retroverted uterus, general body pain, sensation of block in ear, throat pain, fever, chest pain, asthma, allergic rhinitis, vitamin deficiency, penicillin allergy, allergic reaction to antibiotics and upper respiratory infection.Concomitant products included diclofenac sodium (diclofenac al) and naproxen since 2008 for back pain, cyanocobalamin and vitamin d nos (vitamin d) for fatigue as well as codeine phosphate;paracetamol (tylenol with codeine no.3) and salbutamol (albuterol) since 2008.On (b)(6) 2007, the patient had essure inserted.In (b)(6) 2008, the patient experienced anaemia ("anemia/ blood or heart disorder/condition type: anemia").In (b)(6) 2008, the patient experienced pelvic inflammatory disease (seriousness criteria medically significant and intervention required), dyspareunia ("pain during intercourse / dyspareunia ( painful sexual intercourse)"), vaginal infection ("abnormal vaginal infections"), vaginal discharge ("vaginal discharge"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia) / heavy menstrual cycle/heavy periods"), abdominal distension ("bloating"), fatigue ("fatigue"), depression ("psychological or psychiatric problems condition: depression/psych injury") and anxiety ("psychological or psychiatric problems condition: anxiety/psych injury").In (b)(6) 2008, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain") and pain in extremity ("leg pain/ left leg pain").In (b)(6) 2008, the patient experienced migraine ("migraines"), nausea ("nausea"), vulvovaginal mycotic infection ("infection (other) describe: yeast") and eczema ("eczema").In (b)(6) 2008, the patient experienced back pain ("back pain/ pain lower back").In (b)(6) 2008, the patient was found to have weight increased ("other injuries/symptoms : weight gain").In (b)(6) 2008, the patient experienced alopecia ("hair loss").In (b)(6) 2009, the patient experienced urinary tract infection ("bladder or urinary problems or changes: uti").In (b)(6) 2009, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)/ painful menstrual cycle").In (b)(6) 2009, the patient was found to have weight decreased ("weight loss").In (b)(6) 2016, the patient experienced headache ("headaches").In (b)(6) 2016, the patient experienced hypoaesthesia ("leg numbness").On an unknown date, the patient experienced genital haemorrhage ("abnormal bleeding/ bleeding/ plaintiff claiming bleeding: other"), abdominal pain lower ("severe lower abdominal pain"), constipation ("constipation/ other injuries/symptoms : gi conditions"), muscle spasms ("leg cramping"), rash ("allergy: rash/skin condition/ stomach rash"), skin disorder ("skin condition"), decreased appetite ("appetite loss"), dysgeusia ("metal taste"), feeling abnormal ("brain fog") and abdominal pain upper ("stomach area pain").The patient was treated with ferrous sulfate (ferrousul), steroid antibacterials and surgery (full hysterectomy).Essure was removed on (b)(6) 2019.At the time of the report, the pelvic pain, abdominal pain lower, migraine, vaginal infection and vaginal discharge had not resolved, the pelvic inflammatory disease, abdominal pain, headache, alopecia, anaemia, abdominal distension, urinary tract infection, fatigue, weight decreased, hypoaesthesia, nausea, depression, anxiety, constipation, muscle spasms, weight increased, vulvovaginal mycotic infection, decreased appetite, dysgeusia, feeling abnormal and abdominal pain upper outcome was unknown and the genital haemorrhage, back pain, pain in extremity, dyspareunia, vaginal haemorrhage, menorrhagia, dysmenorrhoea, rash, skin disorder and eczema had resolved.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, abdominal pain upper, alopecia, anaemia, anxiety, back pain, constipation, decreased appetite, depression, dysgeusia, dysmenorrhoea, dyspareunia, eczema, fatigue, feeling abnormal, genital haemorrhage, headache, hypoaesthesia, menorrhagia, migraine, muscle spasms, nausea, pain in extremity, pelvic inflammatory disease, pelvic pain, rash, skin disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage, vaginal infection, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2007 and (b)(6) 2008.Discrepancy noted in essure removal date:(b)(6) 2018 and (b)(6) 2019.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.7 kg/sqm.Concerning the injuries reported in this case, the following one/ones were confirm in patient¿s medical records: back pain, fatigue, anemia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-oct-2020: pif received.Events added: appetite loss, metal taste, brain fog, stomach area pain.Reporter's information and rcc were 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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