| Model Number ESS305 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Syncope (1610); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Itching Sensation (1943); Menstrual Irregularities (1959); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Dizziness (2194); Anxiety (2328); Arthralgia (2355); Confusion/ Disorientation (2553); Heavier Menses (2666)
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| Event Date 06/01/2013 |
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Event Type
Injury
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Event Description
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain female") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included bipolar disorder (treatment depakote.), adhd (treatment adderall.), back disorder, psychiatric symptom nos and post-traumatic stress disorder.Previously administered products included for an unreported indication: depakote, adderall, xanax and prozac.Concurrent conditions included obesity.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain ("physical pain"), arthralgia ("joint pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), pruritus ("excessive itching / itchy skin"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), bacterial vaginosis ("bacterial vaginosis"), fungal infection ("yeast infections"), vaginal infection ("vaginal infections"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), amnesia ("memory loss"), cerebral disorder ("brain fo"), confusional state ("confusion"), dizziness ("dizziness"), syncope ("syncope"), allergy to metals ("nickel allergy"), depression ("depression"), anxiety ("anxiety"), mood swings ("mood swings"), panic attack ("panic attacks"), furuncle ("boils on lower abdomen and hips"), vaginal discharge ("vaginal discharge") and weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full), salpingectomy (bilateral removal of fallopian tubes), oophorectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, arthralgia, abdominal pain, back pain, vaginal haemorrhage, pruritus, female sexual dysfunction, dysmenorrhoea, fatigue, alopecia, vaginal infection, migraine, nausea, depression, anxiety and panic attack had resolved and the pain, menorrhagia, dyspareunia, bacterial vaginosis, fungal infection, headache, amnesia, cerebral disorder, confusional state, dizziness, syncope, allergy to metals, mood swings, furuncle, vaginal discharge and weight increased outcome was unknown.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, anxiety, arthralgia, back pain, bacterial vaginosis, cerebral disorder, confusional state, depression, dizziness, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, fungal infection, furuncle, headache, menorrhagia, migraine, mood swings, nausea, pain, panic attack, pelvic pain, pruritus, syncope, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.3 kg/sqm.Hysterosalpingogram - on an unknown date: tubes occluded quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical event is a known possible undesirable event and is not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.Most recent follow-up information incorporated above includes: on 1-mar-2018: plaintiff fact sheet received.Events added from pfs- abnormal bleeding (vaginal/menorrhagia), allergic or hypersensitivity reaction type: excessive itching, apareunia (inability to have sexual intercourse), dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, hair loss, infection (bladder/urinary tract/vaginal) type: bacterial vaginosis, yeast infections, vaginal infections, migraines / headaches, nausea, neurological conditions or problems type: brain fog, memory loss, confusion, dizziness, syncope, nickel allergy, pain, psychological or psychiatric problems condition: depression, anxiety, mood swings, panic attacks, rashes or skin conditions type: boils on lower abdomen and hips, vaginal discharge, weight gain.Concomitant disease, historical condition, historical drug were added.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 pelvic pain ("pelvic pain female") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included back disorder.Previously administered products included for an unreported indication: depakote, adderall, xanax and prozac.Concurrent conditions included obesity, bipolar disorder (treatment depakote.), adhd (treatment adderall.), psychiatric symptom and post-traumatic stress disorder.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain ("physical pain"), arthralgia ("joint pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("abnormal bleeding menorrhagia"), vaginal haemorrhage ("abnormal bleeding vaginal"), female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), bacterial vaginosis ("infection (bladder/urinary tract/vaginal) type: bacterial vaginosis"), fungal infection ("yeast infections"), vaginal infection ("vaginal infections"), migraine ("migraines"), headache ("headaches"), nausea ("nausea"), amnesia ("memory loss"), feeling abnormal ("brain fog"), confusional state ("confusion"), dizziness ("dizziness"), syncope ("syncope"), allergy to metals ("nickel allergy") with pruritus allergic and furuncle, depression ("depression"), anxiety ("anxiety"), mood swings ("mood swings"), panic attack ("panic attacks"), vaginal discharge ("vaginal discharge"), weight increased ("weight gain") and complication of device removal ("complications from your essure removal procedure").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy and right oophorectomy).Essure was removed on 16-feb-2015.At the time of the report, the pelvic pain, arthralgia, abdominal pain, back pain, vaginal haemorrhage, female sexual dysfunction, dysmenorrhoea, dyspareunia, fatigue, alopecia, vaginal infection, migraine, nausea, depression, anxiety and panic attack had resolved and the pain, menorrhagia, bacterial vaginosis, fungal infection, headache, amnesia, feeling abnormal, confusional state, dizziness, syncope, allergy to metals, mood swings, vaginal discharge, weight increased and complication of device removal outcome was unknown.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, anxiety, arthralgia, back pain, bacterial vaginosis, complication of device removal, confusional state, depression, dizziness, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, headache, menorrhagia, migraine, mood swings, nausea, pain, panic attack, pelvic pain, syncope, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.3 kg/sqm.Hysterosalpingogram - on an unknown date: tubes occluded.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical event is a known possible undesirable event and is not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.Most recent follow-up information incorporated above includes: on 8-oct-2018: pfs received: event complication of device removal added.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pain female") in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she didn't went confirmation test".The patient's medical history included back disorder and ectopic pregnancy.Previously administered products included for an unreported indication: prozac, xanax, adderall, depakote, xanax, prozac, depakote and adderall.Concurrent conditions included obesity, bipolar disorder (treatment depakote.), adhd (treatment adderall.), psychiatric symptom and post-traumatic stress disorder.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), arthralgia ("joint pain"), abdominal pain ("abdominal pain"), back pain ("back pain"), menorrhagia ("abnormal bleeding (menorrhagia)"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal discharge ("vaginal discharge").In september 2013, the patient experienced migraine ("migraines") and headache ("headaches").In november 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), alopecia ("hair loss"), bacterial vaginosis ("infection (bladder/urinary tract/vaginal) type: bacterial vaginosis"), fungal infection ("yeast infections"), nausea ("nausea"), amnesia ("memory loss"), feeling abnormal ("brain fog"), confusional state ("confusion"), dizziness ("dizziness"), syncope ("syncope"), depression ("depression"), anxiety ("anxiety"), mood swings ("mood swings") and panic attack ("panic attacks").In may 2014, the patient was found to have weight increased ("weight gain").In november 2014, the patient experienced allergy to metals ("nickel allergy") with pruritus allergic and furuncle.On an unknown date, the patient experienced pain ("physical pain"), vaginal infection ("vaginal infections") and complication of device removal ("complications from your essure removal procedure").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy and right oophorectomy).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, arthralgia, abdominal pain, back pain, vaginal haemorrhage, female sexual dysfunction, dysmenorrhoea, dyspareunia, fatigue, alopecia, vaginal infection, migraine, nausea, depression, anxiety, panic attack and weight increased had resolved, the pain, menorrhagia, bacterial vaginosis, fungal infection, headache, amnesia, feeling abnormal, confusional state, dizziness, syncope, allergy to metals, vaginal discharge and complication of device removal outcome was unknown and the mood swings was resolving.The reporter considered abdominal pain, allergy to metals, alopecia, amnesia, anxiety, arthralgia, back pain, bacterial vaginosis, complication of device removal, confusional state, depression, dizziness, dysmenorrhoea, dyspareunia, fatigue, feeling abnormal, female sexual dysfunction, fungal infection, headache, menorrhagia, migraine, mood swings, nausea, pain, panic attack, pelvic pain, syncope, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.The reporter commented: it was reported that she didn¿t went confirmation test (discrepancy noted).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 32.3 kg/sqm.Hysterosalpingogram: on an unknown date: results: tubes occluded.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time, although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.The reported medical event is a known possible undesirable event and is not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: reporters and historical drug, medical history was added.On (b)(6) 2013, she implanted essure (previously reported as apr-2013).Outcome of event weight gain was recovered and outcome of mood swings was recovering and added onset dates of events.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.
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