| Model Number ESS305 |
| Device Problems
Break (1069); Fracture (1260); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Insufficient Information (3190); Migration (4003)
|
| Patient Problems
Autoimmune Disorder (1732); Fatigue (1849); Failure of Implant (1924); Pain (1994); Rash (2033); Uterine Perforation (2121); Depression (2361); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
|
| Event Date 01/01/2014 |
|
Event Type
Injury
|
|
Event Description
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), autoimmune disorder ("autoimmune disease"), fatigue ("fatigue") and depression ("depression").The patient was treated with surgery (essure device removal).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device dislocation, device breakage, rash, autoimmune disorder, fatigue and depression outcome was unknown.The reporter considered autoimmune disorder, depression, device breakage, device dislocation, fatigue, pelvic pain and rash to be related to essure.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device dislocation ("migration of implant") and device breakage ("fracturing of the implant") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), autoimmune disorder ("autoimmune disease"), fatigue ("fatigue") and depression ("depression").The patient was treated with surgery (essure device removal).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device dislocation, device breakage, rash, autoimmune disorder, fatigue and depression outcome was unknown.The reporter considered autoimmune disorder, depression, device breakage, device dislocation, fatigue, pelvic pain and rash to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-jun-2018: quality safety evaluation of ptc.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain\ pelvic pain\pain on left side"), device dislocation ("migration of implant / essure coils were not visualized"), device breakage ("fracturing of the implant / the medial tip of the left device is fractured\ device breakage found this out upon x-ray due to unexplained pain") and fallopian tube perforation ("the location of the perforation: could see the whole essure through outside of fallopian tube\ you could see one of the essure coils through the outside of my fallopain tube") in a 30-year-old female patient who had essure (batch no.B81397) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included burning micturition, urinary frequency, urinary urgency, obsessive-compulsive disorder, hematuria, yeast infection, vaginal dryness, loss of energy, genital irritation, bladder dysfunction, hormonal imbalance, sinus infection, epigastric burning, vaginal itching, allergic rhinitis, arthralgia, chest pain, fever, abnormal weight gain, muscle spasm, upper respiratory infection, vertigo, viral gastroenteritis, vaginal candidiasis, acute gastritis, incontinence, irritable bowel syndrome, diarrhea, malignant melanoma of skin, loop electrosurgical excision procedure, nabothian cyst, abdominal pain, urticaria, skin breakout, androgenetic alopecia, paratubal cyst, epidermoid cyst, uti on (b)(6) 2013, migraine, common warts and anxiety.Previously administered products included for an unreported indication: luvox, oral contraceptive nos, tri-sprintec, diflucan, terazol and monistat.Past adverse reactions to the above products included loss of libido with tri-sprintec.Concurrent conditions included raynaud's disease and melanoma.Concomitant products included buspirone hydrochloride (buspar) since (b)(6) 2017, fluocinonide, hyoscyamine sulfate (levsin) since (b)(6) 2016, omeprazole from 2014 to 2017, pantoprazole from 2017 to 2018, tretinoin since 2017 and triamcinolone since 2017.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches"), allergy to metals ("nickel allergy") and dysmenorrhoea ("dysmenorrhea (cramping)\ severe menstrual cramps").In (b)(6) 2014, the patient experienced depression ("depression"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: chronic yeast"), anxiety ("psychological or psychiatric problems condition: depression, anxiety, anger issues") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2014, the patient experienced alopecia areata ("auto-immune disorder/alopecia aereata/hairloss/immune system issues") and nausea ("nausea").In (b)(6) 2014, the patient experienced bruxism ("dental problems/worn down teeth from heartburn"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation") and dyspepsia ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) heavy periods which was abnormal for myself"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)heavy periods which was abnormal for myself") and urticaria ("allergic or hypersensitivity reaction type: hives//immune system issues").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), rash ("skin rash"), anger ("psychological or psychiatric problems condition: depression, anxiety, anger issues"), seborrhoeic dermatitis ("rashes or skin conditions type:sebborhiac dermatitis"), oesophagitis ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn"), constipation ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis, constipation,heartburn") and abdominal pain ("abdominal pain").The patient was treated with antidepressants and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, constipation and abdominal pain had resolved, the device dislocation, device breakage, fallopian tube perforation, rash, fatigue, depression, vaginal haemorrhage, menorrhagia, vulvovaginal mycotic infection, anxiety, anger, seborrhoeic dermatitis, migraine, headache, nausea, bruxism, allergy to metals, dysmenorrhoea, dyspareunia and oesophagitis outcome was unknown and the alopecia areata, urticaria, gastrooesophageal reflux disease and dyspepsia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia areata, anger, anxiety, bruxism, constipation, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, dyspepsia, fallopian tube perforation, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, nausea, oesophagitis, pelvic pain, rash, seborrhoeic dermatitis, urticaria, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: 3 trailing coils were there on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: successful occlusion of fallopian tubes with essure implants.X-ray - on (b)(6) 2014: perforation detected.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-apr-2019: pfs received: events- vaginal bleeding, menorrhagia, hives, chronic yeast infection, anxiety, anger issues,seborrhea dermatitis, migraines, headaches, nausea,dental problems,nickel allergy, gerd, dysmenorrhea, dyspareunia, fatigue, g.E.R.D, esophagitis, constipation, heartburn, abdominal pain, fallopian tube perforation.Event verbatim was updated as dental problems/worn down teeth from heartburn and pt fro this was updated to bruxism.Concomitant drugs and treatment drug was added.Ongoing medical history was added.Incident we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), device dislocation ("migration of implant / essure coils were not visualized") and device breakage ("fracturing of the implant / the medial tip of the left device is fractured") in an adult female patient who had essure (batch no.B81397) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included burning micturition, urinary frequency, urinary urgency, obsessive-compulsive disorder, hematuria, yeast infection, vaginal dryness, loss of energy, genital irritation, bladder dysfunction, hormonal imbalance, sinus infection, epigastric burning, vaginal itching, allergic rhinitis, arthralgia, chest pain, fever, abnormal weight gain, muscle spasm, upper respiratory infection, vertigo, viral gastroenteritis, vaginal candidiasis, acute gastritis, incontinence, irritable bowel syndrome, diarrhea, malignant melanoma of skin, loop electrosurgical excision procedure, nabothian cyst, abdominal pain, urticaria, skin breakout, androgenetic alopecia, paratubal cyst, epidermoid cyst, uti on (b)(6) 2013, migraine, common warts and anxiety.Previously administered products included for an unreported indication: luvox, oral contraceptive nos, tri-sprintec, diflucan, terazol and monistat.Past adverse reactions to the above products included loss of libido with tri-sprintec.On (b)(6) 2014, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), rash ("skin rash"), autoimmune disorder ("autoimmune disease"), fatigue ("fatigue") and depression ("depression").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, device dislocation, device breakage, rash, autoimmune disorder, fatigue and depression outcome was unknown.The reporter considered autoimmune disorder, depression, device breakage, device dislocation, fatigue, pelvic pain and rash to be related to essure.The reporter commented: both side 3 trailing coils.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 17-apr-2019: pfs and mr received- lot number, reporter, medical history, lab data.Added.Incident: we received a lot number.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant / the medial tip of the left device is fractured\ device breakage found this out upon x-ray due to unexplained pain"), device dislocation ("migration of implant / essure coils were not visualized"), fallopian tube perforation ("the location of the perforation: could see the whole essure through outside of fallopian tube\ you could see one of the essure coils through the outside of my fallopian tube") and pelvic pain ("pain\ pelvic pain\pain on left side") in a 30-year-old female patient who had essure (batch no.B81397-invalid) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included burning micturition, urinary frequency, urinary urgency, obsessive-compulsive disorder, hematuria, yeast infection, vaginal dryness, loss of energy, genital irritation, bladder dysfunction, hormonal imbalance, sinus infection, epigastric burning, vaginal itching, allergic rhinitis, arthralgia, chest pain, fever, abnormal weight gain, muscle spasm, upper respiratory infection, vertigo, viral gastroenteritis, vaginal candidiasis, acute gastritis, incontinence, irritable bowel syndrome, diarrhea, malignant melanoma of skin, loop electrosurgical excision procedure, nabothian cyst, abdominal pain, urticaria, skin breakout, androgenetic alopecia, paratubal cyst, epidermoid cyst, uti on (b)(6) 2013, migraine, common warts and anxiety.Previously administered products included for an unreported indication: luvox, oral contraceptive nos, tri-sprintec, diflucan, terazol and monistat.Past adverse reactions to the above products included loss of libido with tri-sprintec.Concurrent conditions included raynaud's disease and melanoma.Concomitant products included buspirone hydrochloride (buspar) since (b)(6) 2017, fluocinonide, hyoscyamine sulfate (levsin) since (b)(6) 2016, omeprazole from 2014 to 2017, pantoprazole from 2017 to 2018, tretinoin since 2017 and triamcinolone since 2017.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches"), allergy to metals ("nickel allergy") and dysmenorrhoea ("dysmenorrhea (cramping)\ severe menstrual cramps").In (b)(6) 2014, the patient experienced depression ("depression"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: chronic yeast"), anxiety ("psychological or psychiatric problems condition: depression, anxiety, anger issues") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2014, the patient experienced alopecia areata ("auto-immune disorder/alopecia aereata/hairloss/immune system issues") and nausea ("nausea").In (b)(6) 2014, the patient experienced bruxism ("dental problems/worn down teeth from heartburn"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation") and dyspepsia ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation, heartburn").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) heavy periods which was abnormal for myself"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)heavy periods which was abnormal for myself") and urticaria ("allergic or hypersensitivity reaction type: hives//immune system issues").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), rash ("skin rash"), anger ("psychological or psychiatric problems condition: depression, anxiety, anger issues"), seborrhoeic dermatitis ("rashes or skin conditions type: sebborhiac dermatitis"), oesophagitis ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn"), constipation ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis, constipation, heartburn") and abdominal pain ("abdominal pain").The patient was treated with antidepressants and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, device dislocation, fallopian tube perforation, rash, fatigue, depression, vaginal haemorrhage, menorrhagia, vulvovaginal mycotic infection, anxiety, anger, seborrhoeic dermatitis, migraine, headache, nausea, bruxism, allergy to metals, dysmenorrhoea, dyspareunia and oesophagitis outcome was unknown, the pelvic pain, constipation and abdominal pain had resolved and the alopecia areata, urticaria, gastrooesophageal reflux disease and dyspepsia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia areata, anger, anxiety, bruxism, constipation, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, dyspepsia, fallopian tube perforation, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, nausea, oesophagitis, pelvic pain, rash, seborrhoeic dermatitis, urticaria, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: 3 trailing coils were there on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: successful occlusion of fallopian tubes with essure implants.X-ray - on (b)(6) 2014: perforation detected.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-apr-2019: update of information (batch is invalid).Incident: no valid lot number or device sample was received in this case.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing of the implant / the medial tip of the left device is fractured\ device breakage found this out upon x-ray due to unexplained pain'), device dislocation ('migration of implant / essure coils were not visualized'), fallopian tube perforation ('the location of the perforation: could see the whole essure through outside of fallopian tube\ you could see one of the essure coils through the outside of my fallopain tube') and pelvic pain ('pain\ pelvic pain\pain on left side') in a 30-year-old female patient who had essure (batch no.B81397-not valid,b61397) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included uti on (b)(6) 2013, burning micturition, urinary frequency, urinary urgency, obsessive-compulsive disorder, hematuria, yeast infection, vaginal dryness, loss of energy, genital irritation, bladder dysfunction, hormonal imbalance, sinus infection, epigastric burning, vaginal itching, allergic rhinitis, arthralgia, chest pain, fever, abnormal weight gain, muscle spasm, upper respiratory infection, vertigo, viral gastroenteritis, vaginal candidiasis, acute gastritis, incontinence, irritable bowel syndrome, diarrhea, malignant melanoma of skin, loop electrosurgical excision procedure, nabothian cyst, abdominal pain, urticaria, skin breakout, androgenetic alopecia, paratubal cyst, epidermoid cyst, migraine, common warts and anxiety.Previously administered products included for an unreported indication: luvox, oral contraceptive nos, tri-sprinted, diflucan, terrazole and monistat.Past adverse reactions to the above products included loss of libido with tri-sprinted.Concurrent conditions included raynaud's disease, melanoma and bladder infection.Concomitant products included buspirone hydrochloride (buspar) since (b)(6) 2017, fluocinonide, hyoscyamine sulfate (levsin) since (b)(6) 2016, omeprazole from 2014 to 2017, pantoprazole from 2017 to 2018, tretinoin since 2017 and triamcinolone since 2017.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches"), allergy to metals ("nickel allergy") and dysmenorrhoea ("dysmenorrhea (cramping)\ severe menstrual cramps").In june 2014, the patient experienced depression ("depression"), vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: chronic yeast"), anxiety ("psychological or psychiatric problems condition: depression, anxiety, anger issues") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2014, the patient experienced alopecia areata ("auto-immune disorder/alopecia aereata/hairloss/immune system issues") and nausea ("nausea").In (b)(6) 2014, the patient experienced bruxism ("dental problems/worn down teeth from heartburn"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation") and dyspepsia ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn").In (b)(6) 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), fatigue ("fatigue"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) heavy periods which was abnormal for myself"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)heavy periods which was abnormal for myself") and urticaria ("allergic or hypersensitivity reaction type: hives//immune system issues").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), rash ("skin rash"), anger ("psychological or psychiatric problems condition: depression, anxiety, anger issues"), seborrhoeic dermatitis ("rashes or skin conditions type:seborrheica dermatitis"), oesophagitis ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn"), constipation ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis, constipation,heartburn") and abdominal pain ("abdominal pain").The patient was treated with antibiotics, antidepressants and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, device dislocation, fallopian tube perforation, rash, fatigue, depression, vaginal haemorrhage, menorrhagia, vulvovaginal mycotic infection, anxiety, anger, seborrhoeic dermatitis, migraine, headache, nausea, bruxism, allergy to metals, dysmenorrhoea, dyspareunia and oesophagitis outcome was unknown, the pelvic pain, constipation and abdominal pain had resolved and the alopecia areata, urticaria, gastrooesophageal reflux disease and dyspepsia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia areata, anger, anxiety, bruxism, constipation, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, dyspepsia, fallopian tube perforation, fatigue, gastrooesophageal reflux disease, headache, menorrhagia, migraine, nausea, oesophagitis, pelvic pain, rash, seborrhoeic dermatitis, urticaria, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.The reporter commented: 3 trailing coils were there on both sides.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: successful occlusion of fallopian tubes with essure implants that there was no flow along my fallopian tubes and that the essure procedure had worked total bilateral occlusion.X-ray - on (b)(6) 2014: perforation detected.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received: lot number were added.Medical history, treatment drug were added.We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing of the implant / the medial tip of the left device is fractured\ device breakage found this out upon x-ray due to unexplained pain'), device dislocation ('migration of implant / essure coils were not visualized'), fallopian tube perforation ('the location of the perforation: could see the whole essure through outside of fallopian tube\ you could see one of the essure coils through the outside of my fallopian tube') and pelvic pain ('pain\ pelvic pain\pain on left side') in a 30-year-old female patient who had essure (batch no.B81397- not valid,b61397) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included uti on (b)(6) 2013, burning micturition, urinary frequency, urinary urgency, obsessive-compulsive disorder, hematuria, yeast infection, vaginal dryness, loss of energy, genital irritation, bladder dysfunction, hormonal imbalance, sinus infection, epigastric burning, vaginal itching, allergic rhinitis, arthralgia, chest pain, fever, abnormal weight gain, muscle spasm, upper respiratory infection, vertigo, viral gastroenteritis, vaginal candidiasis, acute gastritis, incontinence, irritable bowel syndrome, diarrhea, malignant melanoma of skin, loop electrosurgical excision procedure, nabothian cyst, abdominal pain, urticaria, skin breakout, androgenetic alopecia, paratubal cyst, epidermoid cyst, migraine, common warts and anxiety.Previously administered products included for an unreported indication: luvox, oral contraceptive nos, tri-sprintec, diflucan, terazol and monistat.Past adverse reactions to the above products included loss of libido with tri-sprintec.Concurrent conditions included raynaud's disease, melanoma and bladder infection.Concomitant products included buspirone hydrochloride (buspar) since march 2017, fluocinonide, hyoscyamine sulfate (levsin) since august 2016, omeprazole from 2014 to 2017, pantoprazole from 2017 to 2018, tretinoin since 2017 and triamcinolone since 2017.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required), allergy to metals ("nickel allergy"), dysmenorrhoea ("dysmenorrhea (cramping)\ severe menstrual cramps") and migraine ("migraines/headache").In june 2014, the patient experienced vulvovaginal mycotic infection ("infection (bladder/ urinary tract/vaginal) type: chronic yeast"), depression ("depression"), anxiety ("psychological or psychiatric problems condition: depression, anxiety, anger issues") and dyspareunia ("dyspareunia (painful sexual intercourse)").In july 2014, the patient experienced alopecia areata ("auto-immune disorder/alopecia aereata/hairloss/immune system issues") and nausea ("nausea").In september 2014, the patient experienced bruxism ("dental problems/worn down teeth from heartburn"), gastrooesophageal reflux disease ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation") and dyspepsia ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn").In january 2015, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), urticaria ("allergic or hypersensitivity reaction type: hives//immune system issues"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia) heavy periods which was abnormal for myself"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)heavy periods which was abnormal for myself") and fatigue ("fatigue").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), fallopian tube perforation (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), rash ("skin rash"), seborrhoeic dermatitis ("rashes or skin conditions type:sebborhiac dermatitis"), anger ("psychological or psychiatric problems condition: depression, anxiety, anger issues"), oesophagitis ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis constipation,heartburn") and constipation ("gastrointestinal or digestive system condition type: g.E.R.D, esophagitis, constipation,heartburn").The patient was treated with antibiotics, antidepressants and surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2017.At the time of the report, the device breakage, device dislocation, fallopian tube perforation, allergy to metals, rash, seborrhoeic dermatitis, vaginal haemorrhage, menorrhagia, vulvovaginal mycotic infection, dysmenorrhoea, fatigue, depression, anxiety, anger, migraine, nausea, bruxism, dyspareunia and oesophagitis outcome was unknown, the pelvic pain, abdominal pain and constipation had resolved and the urticaria, alopecia areata, gastrooesophageal reflux disease and dyspepsia was resolving.The reporter considered abdominal pain, allergy to metals, alopecia areata, anger, anxiety, bruxism, constipation, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, dyspepsia, fallopian tube perforation, fatigue, gastrooesophageal reflux disease, menorrhagia, migraine, nausea, oesophagitis, pelvic pain, rash, seborrhoeic dermatitis, urticaria, vaginal haemorrhage and vulvovaginal mycotic infection to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: successful occlusion of fallopian tubes with essure implants that there was no flow along my fallopian tubes and that the essure procedure had worked total bilateral occlusion.X-ray - on (b)(6) 2014: perforation detected.Lot b81397 is not valid.Lot number: b61397 expiration date-31aug2016, production date -26aug2013.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc(product technical complaint).We received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
|
| |
|
Search Alerts/Recalls
|
|
