| Model Number ESS305 |
| Device Problems
Break (1069); Detachment Of Device Component (1104); Malposition of Device (2616); Biocompatibility (2886); Device Dislodged or Dislocated (2923); Migration (4003)
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| Patient Problems
Rheumatoid Arthritis (1724); Fatigue (1849); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Rash (2033); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Visual Impairment (2138); Burning Sensation (2146); Anxiety (2328); Depression (2361); Fungal Infection (2419); Weight Changes (2607); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 12/01/2010 |
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Event Type
malfunction
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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 ("malposition of essure device (it feels as though the essure device is not in the proper location, i can feel this when lie down)"), fallopian tube perforation ("perforation (fallopian tube(s))"), device breakage ("device breakage/ it has moved and parts have broken off"), kidney infection ("infection -recurring kidney") and rheumatoid arthritis ("rheumatoid arthritis (in hands hips, and knees)") in a (b)(6) female patient who had essure (batch no.20182548) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity (worsened post essure placement procedure) in 1996, rash on face (worsened post essure placement procedure) in 1996, gravida i (.), live birth (1) in 2007, colitis (last colo (b)(6) 2014), proctitis, sunburn, bursitis, tonsillectomy and knee operation.Previously administered products included for an unreported indication: motrin, vicodin, erythromycin base, depoprovera, doxycycline hyclate and serax.Past adverse reactions to the above products included nausea with erythromycin base; and rash with doxycycline hyclate.Concurrent conditions included iodine allergy, shellfish allergy, connective tissue disorder, esophageal reflux, latex allergy (latex), contrast media allergy, vaginal odour, vaginal discharge abnormality, connective tissue disorder, skin melanoma, raynauds, trochanteric syndrome, scleroderma, crohn's disease, adnexa uteri pain, sneezing and cough.Family history included coronary artery disease, cancer of lung, hepatic cancer, prostate cancer and pancreatic cancer.Concomitant products included sulfasalazine (sulfazine) for ulcerative colitis as well as cyclobenzaprine hydrochloride, folic acid, hyoscyamine sulfate, melatonin, omeprazole, oxazepam (serax), paroxetine hydrochloride, tramadol hydrochloride and trazodone hydrochloride (trazodone hcl).On (b)(6) 2010, the patient had essure inserted.On the same day, the patient experienced fallopian tube perforation (seriousness criterion medically significant) with pelvic pain and adnexa uteri pain ("tubes are in pain/ feel like my tubes are going to pop").In 2011, the patient experienced fatigue ("fatigue"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), migraine ("migraines"), nausea ("nausea"), eye disorder ("vision / eye problems (vision seems to get worse even though i have glasses)"), visual impairment ("vision / eye problems (vision seems to get worse even though i have glasses)"), vaginal discharge ("vaginal discharge"), weight increased ("weight gain") and the first episode of memory impairment ("forgetfulness").In 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("menorrhagia") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In 2014, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), fibromyalgia ("autoimmune disorder (fibromyalgia) i also have fibromyalgia,") with pain in extremity and back pain, rheumatoid arthritis (seriousness criterion medically significant) and depression ("psychological or psychiatric problems (depression)/very depressed with everything life").In 2016, the patient experienced colitis ulcerative ("ulcerative colitis worsening").In 2017, the patient experienced kidney infection (seriousness criterion medically significant), heart rate increased ("blood or heart disorder/condition (more beats per second)") and fungal infection ("yeast infections").On an unknown date, the patient experienced allergy to metals ("nickel allergy") with rash, burning sensation ("hands and feet feel like they are on fire"), headache ("headaches"), the second episode of memory impairment ("neurological conditions or problems (hard time remember a few minutes ago or simple information.)"), stress ("gets stressed out easier"), anxiety ("anxiety"), amnesia ("memory loss") and coccydynia ("pelvic pain including my tail bone").The patient was treated with gabapentin, amitriptyline, paracetamol (tylenol), povidone-iodine (betadin), scandicaine (mepivacaine w/epinephrine), lidocaine and ibuprofen.Essure treatment was not changed.At the time of the report, the device dislocation, fallopian tube perforation, device breakage, kidney infection, vaginal haemorrhage, menorrhagia, fibromyalgia, burning sensation, colitis ulcerative, rheumatoid arthritis, heart rate increased, dysmenorrhoea, dyspareunia, fatigue, alopecia, hormone level abnormal, fungal infection, migraine, headache, nausea, the last episode of memory impairment, depression, stress, anxiety, eye disorder, visual impairment, vaginal discharge, weight increased, adnexa uteri pain, amnesia and coccydynia had not resolved and the allergy to metals outcome was unknown.The reporter considered adnexa uteri pain, allergy to metals, alopecia, amnesia, anxiety, burning sensation, coccydynia, colitis ulcerative, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, eye disorder, fallopian tube perforation, fatigue, fibromyalgia, fungal infection, headache, heart rate increased, hormone level abnormal, kidney infection, menorrhagia, migraine, nausea, rheumatoid arthritis, stress, vaginal discharge, vaginal haemorrhage, visual impairment, weight increased, the first episode of memory impairment and the second episode of memory impairment to be related to essure.The reporter commented: patient use cold water to treat the flare ups on my toes.Otc meds used: tylenol, advil i have constant pain that worsens from actions such as sneezing, coughing, going to the bathroom, or walking.I also have fibromyalgia, so i experience pain in multiple areas including my arms, back, and leg.I also have a nickel allergy and had occasional skin reactions.All of my conditions were well controlled before, but became much worse after the essure placement procedure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Pregnancy test - on (b)(6) 2010: negative.On (b)(6) 2011 and, patient had performed by hysterosalpingogram test after three month her procedure, result the dye test indicates that both tubes are completely blocked.On (b)(6) 2014, xrhysterosalpingogram findings: normal appearance of the endometrial cavity is identified.No filling defect is seen.There is no contrast opacification of the fallopian tubes.Bilateral tubal occlusion wires are appropriate in configuration in relation to the uterus.The endometrial cavity was sounded to 7 cm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: persistent pelvic pain, vaginal bleeding, very minor cramping, lower back pain, right knee swollen x 2 weeks.Prickly feeling.Today tailbone pain.Feet, ankle feel tight, esophageal reflux, depression, anxiety disorder, feeling tired (fatigue), pain with sex.Most recent follow-up information incorporated above includes: on 27-feb-2018: case became medically confirm.Concomitant condition added from medical record.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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Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("malposition of essure device (it feels as though the essure device is not in the proper location, i can feel this when lie down)"), fallopian tube perforation ("perforation (fallopian tube(s))"), device breakage ("device breakage/ it has moved and parts have broken off/notice some fragments"), kidney infection ("infection -recurring kidney") and rheumatoid arthritis ("rheumatoid arthritis (in hands hips, and knees)") in a 31-year-old female patient who had essure (batch no.20182548) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included nickel sensitivity (worsened post essure placement procedure) in 1996, rash on face (worsened post essure placement procedure) in 1996, gravida i (.), live birth (1) in 2007, colitis (last colo nov2014), proctitis, sunburn, bursitis, tonsillectomy and knee operation.Previously administered products included for an unreported indication: doxycycline hyclate, erythromycin base, depoprovera, vicodin, serax and motrin.Past adverse reactions to the above products included nausea with erythromycin base; and rash with doxycycline hyclate.Concurrent conditions included iodine allergy, shellfish allergy, connective tissue disorder, esophageal reflux, latex allergy (latex), contrast media allergy, vaginal odour, vaginal discharge abnormality, connective tissue disorder, skin melanoma, raynauds, trochanteric syndrome, scleroderma, crohn's disease, adnexa uteri pain, sneezing, cough and abdominal pain lower.Family history included coronary artery disease, cancer of lung, hepatic cancer, prostate cancer and pancreatic cancer.Concomitant products included sulfasalazine (sulfazine) for ulcerative colitis as well as cyclobenzaprine hydrochloride, folic acid, hyoscyamine sulfate, melatonin, omeprazole, oxazepam (serax), paroxetine hydrochloride, tramadol hydrochloride and trazodone hydrochloride (trazodone hcl).On 1-dec-2010, the patient had essure inserted.On the same day, the patient experienced fallopian tube perforation (seriousness criterion medically significant) with pelvic pain and adnexa uteri pain ("tubes are in pain/ feel like my tubes are going to pop").In 2011, the patient experienced fatigue ("fatigue"), alopecia ("hair loss"), hormone level abnormal ("hormonal changes"), migraine ("migraines"), nausea ("nausea"), eye disorder ("vision / eye problems (vision seems to get worse even though i have glasses)"), visual impairment ("vision / eye problems (vision seems to get worse even though i have glasses)"), vaginal discharge ("vaginal discharge"), weight increased ("weight gain") and the first episode of memory impairment ("forgetfulness").In 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal/menorrhagia)"), menorrhagia ("menorrhagia") and dysmenorrhoea ("dysmenorrhea (cramping)").In 2013, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").In 2014, the patient experienced device dislocation (seriousness criterion medically significant), device breakage (seriousness criterion medically significant), fibromyalgia ("autoimmune disorder (fibromyalgia) i also have fibromyalgia,") with pain in extremity and back pain, rheumatoid arthritis (seriousness criterion medically significant) and depression ("psychological or psychiatric problems (depression)/very depressed with everything life").In 2016, the patient experienced colitis ulcerative ("ulcerative colitis worsening").In 2017, the patient experienced kidney infection (seriousness criterion medically significant), heart rate increased ("blood or heart disorder/condition (more beats per second)") and fungal infection ("yeast infections").On an unknown date, the patient experienced allergy to metals ("nickel allergy") with rash, burning sensation ("hands and feet feel like they are on fire"), headache ("headaches"), the second episode of memory impairment ("neurological conditions or problems (hard time remember a few minutes ago or simple information.)"), stress ("gets stressed out easier"), anxiety ("anxiety"), amnesia ("memory loss") and coccydynia ("pelvic pain including my tail bone").The patient was treated with gabapentin, amitriptyline, paracetamol (tylenol), povidone-iodine (betadin), scandicaine (mepivacaine w/epinephrine), lidocaine and ibuprofen.Essure treatment was not changed.At the time of the report, the device dislocation, fallopian tube perforation, device breakage, kidney infection, vaginal haemorrhage, menorrhagia, fibromyalgia, burning sensation, colitis ulcerative, rheumatoid arthritis, heart rate increased, dysmenorrhoea, dyspareunia, fatigue, alopecia, hormone level abnormal, fungal infection, migraine, headache, nausea, the last episode of memory impairment, depression, stress, anxiety, eye disorder, visual impairment, vaginal discharge, weight increased, adnexa uteri pain, amnesia and coccydynia had not resolved and the allergy to metals outcome was unknown.The reporter considered adnexa uteri pain, allergy to metals, alopecia, amnesia, anxiety, burning sensation, coccydynia, colitis ulcerative, depression, device breakage, device dislocation, dysmenorrhoea, dyspareunia, eye disorder, fallopian tube perforation, fatigue, fibromyalgia, fungal infection, headache, heart rate increased, hormone level abnormal, kidney infection, menorrhagia, migraine, nausea, rheumatoid arthritis, stress, vaginal discharge, vaginal haemorrhage, visual impairment, weight increased, the first episode of memory impairment and the second episode of memory impairment to be related to essure.The reporter commented: patient use cold water to treat the flare ups on my toes.Otc meds used: tylenol, advil i have constant pain that worsens from actions such as sneezing, coughing, going to the bathroom, or walking.I also have fibromyalgia, so i experience pain in multiple areas including my arms, back, and leg.I also have a nickel allergy and had occasional skin reactions.All of my conditions were well controlled before, but became much worse after the essure placement procedure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 17.5 kg/sqm.Pregnancy test - on 1-dec-2010: negative on march-2011 and , patient had performed by hysterosalpingogram test after three month her procedure, result the dye test indicates that both tubes are completely blocked.06-may-2014, xrhysterosalpingogram findings: normal appearance of the endometrial cavity is identified.No filling defect is seen.There is no contrast opacification of the fallopian tubes.Bilateral tubal occlusion wires are appropriate in configuration in relation to the uterus.The endometrial cavity was sounded to 7 cm.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: persistent pelvic pain, vaginal bleeding, very minor cramping, lower back pain, right knee swollen x 2 weeks.Prickly feeling.Today tailbone pain.Feet, ankle feel tight, esophageal reflux, depression, anxiety disorder, feeling tired (fatigue), pain with sex.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 30-jul-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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Search Alerts/Recalls
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