| Model Number ESS305 |
| Device Problems
Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Activation Failure (3270); Migration (4003)
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| Patient Problems
Rheumatoid Arthritis (1724); Erythema (1840); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Pelvic Inflammatory Disease (2000); Rash (2033); Tinnitus (2103); Vertigo (2134); Burning Sensation (2146); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Depression (2361); Fungal Infection (2419); Abdominal Distention (2601); Foreign Body In Patient (2687); No Code Available (3191)
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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 dislocation ("the coils seemed to be out of place."), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), meniere's disease ("meniere¿s disease") and rheumatoid arthritis ("rheumatoid arthritis") in a (b)(6)-year-old female patient who had essure (batch no.(b)(4)) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's past medical history included migraine in 2002, knee pain in 1997, migraine, anxiety, oral contraception from 2013 to 2014, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), the first episode of arthralgia ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube.").On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), rash erythematous ("nickel cause redness"), migraine ("migraines") and the second episode of arthralgia ("knee pain").The patient was treated with cortisone, buspirone hydrochloride (buspar), hydroxychloroquine phosphate (plaquenil), spironolactone, tizanidine, medroxyprogesterone (depo provera) and surgery (laparoscopic hysterectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, rash erythematous, migraine, complication of device insertion and fallopian tube spasm outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis and the last episode of arthralgia had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, complication of device insertion, depression, device dislocation, dizziness, fallopian tube spasm, fungal infection, genital haemorrhage, meniere's disease, migraine, rash erythematous, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, the first episode of arthralgia and the second episode of arthralgia to be related to essure.No further causality assessment were provided for the product.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).On (b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: bilateral fallopian tube occlusion pregnancy test - on an unknown date: negative.Current weight: (b)(6); approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.-she had essure confirmation test, hysterosalpingogram (hsg) on (b)(6) 2015.-on (b)(6) 2015 office visit, it was reported that she underwent confirmation test in three months.Most recent follow-up information incorporated above includes: on (b)(6) 2017: reporter information was updated.This case concerns (b)(6) year old patient.Patient demographics were updated.Historical condition/ historical medication/concomitant disease were added.Lab data was added.Essure indication was added.Essure implantation ((b)(6) 2014/ (b)(6) 2015) and explanation date was added.Treatment medications were added.Event¿s: bleeding being caused by essure/excessive bleeding/ bleeding (2014); the coils seemed to be out of place with constant pain being caused by essure/pain/persistent pelvic stabbing pain/pain and suffering (2014) and abdominal pain (severe); bleeding being caused by essure/excessive bleeding/ bleeding; bloating; constant yeast infections; depression; rheumatoid arthritis; meniere¿s disease; severe joint pain (swelling pressure); dizziness; ringing in ears; vaginal burning; mental anguish/anxiety; vertigo; hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness.Incident.At the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("the coils seemed to be out of place."), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), meniere's disease ("meniere¿s disease") and rheumatoid arthritis ("rheumatoid arthritis") in a 36-year-old female patient who had essure (batch no.Cs000n0 (valid)/ b60754 (invalid)) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's past medical history included migraine in 2002, knee pain in 1997, migraine, anxiety, oral contraception from 2013 to 2014, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), the first episode of arthralgia ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2015, 2 months 18 days after insertion of essure, the patient experienced complication of device insertion ("coil did not deploy properly in left tube.").On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines") and the second episode of arthralgia ("knee pain").The patient was treated with cortisone, buspirone hydrochloride (buspar), hydroxychloroquine phosphate (plaquenil), spironolactone, tizanidine, medroxyprogesterone (depo provera) and surgery (laparoscopic hysterectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion and fallopian tube spasm outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis and the last episode of arthralgia had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fungal infection, genital haemorrhage, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, the first episode of arthralgia and the second episode of arthralgia to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).(b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: bilateral fallopian tube occlusion pregnancy test - on an unknown date: negative current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.-she had essure confirmation test, hysterosalpingogram (hsg) on (b)(6) 2015.-on (b)(6) 2015 office visit, it was reported that she underwent confirmation test in three months.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("the coils seemed to be out of place."), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), meniere's disease ("meniere¿s disease") and rheumatoid arthritis ("rheumatoid arthritis") in a 36-year-old female patient who had essure (batch no.Cs000n0-valid/b60754-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on 27-oct-2015.The patient's past medical history included migraine in 2002, knee pain in 1997, migraine, anxiety, oral contraception from 2013 to 2014, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), the first episode of arthralgia ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, 2 months 18 days after insertion of essure, the patient experienced complication of device insertion ("coil did not deploy properly in left tube.").On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines") and the second episode of arthralgia ("knee pain").The patient was treated with cortisone, buspirone hydrochloride (buspar), hydroxychloroquine phosphate (plaquenil), spironolactone, tizanidine, medroxyprogesterone (depo provera) and surgery (laparoscopic hysterectomy).Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion and fallopian tube spasm outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis and the last episode of arthralgia had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fungal infection, genital haemorrhage, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, the first episode of arthralgia and the second episode of arthralgia to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).(b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 27-apr-2015: bilateral fallopian tube occlusion pregnancy test - on an unknown date: negative current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.-she had essure confirmation test, hysterosalpingogram (hsg) on 27-apr-2015.-on 13-jan-2015 office visit, it was reported that she underwent confirmation test in three months.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 19-jul-2018: quality safety evaluation of product technical complaint.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('the coils seemed to be out of place.'), genital haemorrhage ('bleeding being caused by essure/excessive bleeding/ bleeding'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0-valid/b60754-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines"), knee pain ("knee pain"), bacterial vaginosis ("bv"), vulvovaginal pruritus ("itching awful"), insomnia ("i am not sleeping well"), headache ("headaches") and fatigue ("tired all the time").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion, fallopian tube spasm, bacterial vaginosis, vulvovaginal pruritus, insomnia, headache and fatigue outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis, joint pain and knee pain had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, bacterial vaginosis, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fatigue, fungal infection, genital haemorrhage, headache, insomnia, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, vulvovaginal pruritus and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).On (b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.* current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Concerning the injuries reported in this case, the following one was described in patient¿s social media: insomnia, sleep disturbance and headache.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media received.Events added: i am not sleeping well, tired all the time and headaches.Reporter 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-conformances data; should any new and reportable information become available as a result, 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 dislocation ('the coils seemed to be out of place.'), genital haemorrhage ('bleeding being caused by essure/excessive bleeding/ bleeding'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0-valid/b60754-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines"), knee pain ("knee pain"), bacterial vaginosis ("bv") and vulvovaginal pruritus ("itching awful").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion, fallopian tube spasm, bacterial vaginosis and vulvovaginal pruritus outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis, joint pain and knee pain had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, bacterial vaginosis, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fungal infection, genital haemorrhage, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, vulvovaginal pruritus and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).On (b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.* current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 2-dec-2019: social media content received: reporter added.Events: bacterial vaginosis, itching 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-conformances data; should any new and reportable information become available as a result, 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 dislocation ('the coils seemed to be out of place.'), genital haemorrhage ('bleeding being caused by essure/excessive bleeding/ bleeding'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0-valid/b60754-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines") and knee pain ("knee pain").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion and fallopian tube spasm outcome was unknown, the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved and the rheumatoid arthritis, joint pain and knee pain had not resolved.The reporter considered abdominal distension, allergy to metals, anxiety, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fungal infection, genital haemorrhage, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).(b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.* current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: all source document information, reporter and reference section from deletion case (b)(4) added to this case.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformance's data; should any new and reportable information become available as a result, 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 dislocation ('the coils seemed to be out of place.'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis/arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0valid/b60754notvalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.On (b)(6) 2014, the patient had essure inserted.In 2014, the patient experienced meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines"), knee pain ("knee pain"), bacterial vaginosis ("bv"), vulvovaginal pruritus ("itching awful"), insomnia ("i am not sleeping well"), headache ("headaches") and fatigue ("tired all the time").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion, fallopian tube spasm, bacterial vaginosis, vulvovaginal pruritus, insomnia, headache and fatigue outcome was unknown, the rheumatoid arthritis, joint pain and knee pain had not resolved and the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved.The reporter considered abdominal distension, allergy to metals, anxiety, bacterial vaginosis, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fatigue, fungal infection, genital haemorrhage, headache, insomnia, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, vulvovaginal pruritus and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).On (b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.* current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Concerning the injuries reported in this case, the following one was described in patient¿s social media: insomnia, sleep disturbance and headache.Lot number (b60764) is not valid.Lot number: cs000n0 udi: b)(4) cs000n0 manufacture date: 2014-10.Expiration date: 2017-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-feb-2020: quality safety evaluation of ptc.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 dislocation ('the coils seemed to be out of place.'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis/arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0-valid/b60754-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines"), knee pain ("knee pain"), bacterial vaginosis ("bv"), vulvovaginal pruritus ("itching awful"), insomnia ("i am not sleeping well"), headache ("headaches") and fatigue ("tired all the time").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion, fallopian tube spasm, bacterial vaginosis, vulvovaginal pruritus, insomnia, headache and fatigue outcome was unknown, the rheumatoid arthritis, joint pain and knee pain had not resolved and the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved.The reporter considered abdominal distension, allergy to metals, anxiety, bacterial vaginosis, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fatigue, fungal infection, genital haemorrhage, headache, insomnia, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, tinnitus, vertigo, vulvovaginal burning sensation, vulvovaginal pruritus and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).(b)(6) 2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.* current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).-seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Concerning the injuries reported in this case, the following one was described in patient¿s social media: insomnia, sleep disturbance and headache.Quality-safety evaluation of ptc: unable to confirm complaint most recent follow-up information incorporated above includes: on (b)(6) 2020: all information like reporters, source document, events and reference section from deletion case: (b)(4) was added to this case.Event clubbed: rheumatoid arthritis/arthritis.A technical investigation will be 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 dislocation ('the coils seemed to be out of place.'), salpingitis ('tube were so inflamed'), meniere's disease ('meniere¿s disease') and rheumatoid arthritis ('rheumatoid arthritis/arthritis') in a 36-year-old female patient who had essure (batch no.Cs000n0valid/b60754notvalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "tube spasm caused difficult placement of right tubes same with left tube." on (b)(6) 2015.The patient's medical history included oral contraception from 2013 to 2014, migraine in 2002, knee pain in 1997, migraine, anxiety, genital warts, ex-smoker, alcohol use (there is a history of alcohol use.10-12 weekends consumed weekly.), caffeine consumption (1-2 a week a day.), menarche (at 12 years of age), menses irregular and tubal ligation.She had not pregnant at any time.Previously administered products included for an unreported indication: sulfa and penicillin.Past adverse reactions to the above products included arthralgia with sulfa; and urticaria with penicillin.Concurrent conditions included bicornuate uterus, condyloma acuminatum and libido decreased.In 2014, the patient experienced meniere's disease (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant), genital haemorrhage ("bleeding being caused by essure/excessive bleeding/ bleeding"), abdominal distension ("bloating"), fungal infection ("constant yeast infections"), depression ("depression"), joint pain ("severe joint pain (swelling pressure)"), tinnitus ("ringing in ears"), vulvovaginal burning sensation ("vaginal burning"), anxiety ("mental anguish/anxiety") and allergy to metals ("hypersensitivity reaction to nickel or any other component of essure/super sensitive to cheap jewelry made with nickel cause redness and burning").On (b)(6) 2014, the patient had essure inserted.On (b)(6) 2015, the patient experienced complication of device insertion ("coil did not deploy properly in left tube."), 2 months 18 days after insertion of essure.On (b)(6) 2015, the patient experienced fallopian tube spasm ("tube spasm caused difficult placement of right tubes same with left tube.").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, salpingitis (seriousness criteria medically significant and intervention required), post-traumatic stress disorder ("ptsd"), dizziness ("dizziness"), vertigo ("vertigo"), dermatitis contact ("nickel cause redness"), migraine ("migraines"), knee pain ("knee pain"), bacterial vaginosis ("bv"), vulvovaginal pruritus ("itching awful"), insomnia ("i am not sleeping well"), headache ("headaches"), fatigue ("tired all the time") and alopecia ("hair loss").The patient was treated with buspirone hydrochloride (buspar), cortisone, hydroxychloroquine, medroxyprogesterone acetate (depo provera), spironolactone, tizanidine, ice, heat, surgery (laparoscopic hysterectomy), patient exercises and re counseling.Essure was removed on (b)(6) 2015.At the time of the report, the device dislocation, salpingitis, meniere's disease, fungal infection, post-traumatic stress disorder, depression, dizziness, tinnitus, anxiety, vertigo, allergy to metals, dermatitis contact, migraine, complication of device insertion, fallopian tube spasm, bacterial vaginosis, vulvovaginal pruritus, insomnia, headache, fatigue and alopecia outcome was unknown, the rheumatoid arthritis, joint pain and knee pain had not resolved and the genital haemorrhage, abdominal distension and vulvovaginal burning sensation had resolved.The reporter considered abdominal distension, allergy to metals, alopecia, anxiety, bacterial vaginosis, complication of device insertion, depression, dermatitis contact, device dislocation, dizziness, fallopian tube spasm, fatigue, fungal infection, genital haemorrhage, headache, insomnia, joint pain, meniere's disease, migraine, post-traumatic stress disorder, rheumatoid arthritis, salpingitis, tinnitus, vertigo, vulvovaginal burning sensation, vulvovaginal pruritus and knee pain to be related to essure.The reporter commented: date of insertion right essure: (b)(6) 2014; date of insertion left essure: (b)(6) 2015 (3 trailing coil on the right tube.Unable to place device on the left).She was diagnosed autoimmune disorder: rheumatoid arthritis, meniere¿s disease.Physician states incorrectly that each procedure took 15-20 minutes.It was actually closer to 45-60 minutes.Condoms-std prevention, not for very long after placement between 2014-2015.After removal, these symptoms resolved: bloating, bleeding, persistent pelvic stabbing pain, vaginal burning.Allergy tlo latex (hives).08-jul-2015 : she was writing to dispute your refusal to cover her essure confirmation test (hysterosalpingogram) on (b)(6) 2015 with physician.Please see attached document stating that the procedure cannot be performed if the patient is experiencing vaginal bleeding which she was and that was the reason for the delay in the procedure.Current weight: 219; approximate weight at the time of essure placement: 230 (units unspecified).Seminole hearing tests.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: results: bilateral fallopian tube occlusion.Pregnancy test - on an unknown date: results: negative.Concerning the injuries reported in this case, the following one was described in patient¿s social media: insomnia, sleep disturbance and headache.Lot number (b60764) is not valid.Lot number: cs000n0 udi: (b)(4) cs000n0 manufacture date: 2014-10 expiration date: 2017-08.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-mar-2020: social media content received: events: tubes were inflamed ad hair loss were added.Reporter 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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