| Model Number ESS205 |
| Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problems
Chest Pain (1776); Diarrhea (1811); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Inflammation (1932); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Skin Irritation (2076); Tachycardia (2095); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Anxiety (2328); Depression (2361); Fungal Infection (2419); Weight Changes (2607)
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| Event Date 01/01/2011 |
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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 ("pain") in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced diarrhoea ("gastrointestinal or digestive system condition; type: diarrhea").In 2008, the patient experienced alopecia ("hair loss").In 2009, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2010, the patient experienced tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: anxiety"), mood swings ("psychological or psychiatric problems condition: mood swings"), dry skin ("dry skin"), rash ("rashes") and vision blurred ("blurry vision").In 2011, the patient experienced stress urinary incontinence ("bladder or urinary problems or changes : stress incontinence"), chest pain ("blood or heart disorder/condition; type: chest pain"), chest discomfort ("blood or heart disorder/condition; type: tightening"), heart rate increased ("blood or heart disorder/condition; type: pounding heart beat"), dysmenorrhoea ("dysmenorrhea (cramping)"), breast inflammation ("breast inflammation"), the first episode of fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge") and breast pain ("breast pain").In 2012, the patient experienced fatigue ("fatigue").In 2014, the patient experienced migraine ("migraines"), headache ("headaches"), nausea ("nausea"), muscle spasms ("neurological conditions or problems type: muscle spasms in arms and legs"), weight decreased ("weight loss"), weight increased ("weight gain"), arthralgia ("joints pain"), abdominal pain lower ("abdomen pain") and back pain ("back pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain ("physical pain"), food allergy ("allergic or hypersensitivity reaction; type: certain foods") with hiccups and abdominal pain upper, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), constipation ("gastrointestinal or digestive system condition; type: constipation"), abdominal distension ("abdominal bloating"), umbilical hernia ("issues with umbilical hernia"), the second episode of fungal infection ("infection (bladder/urinary tract/vaginal) type: yeast infection"), blepharospasm ("eye twitches"), uterine malposition ("tilted uterus") and pyrexia ("fevers").The patient was treated with surgery (tubouterine implantation, bilateral salpingostomy).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, pain, food allergy, vaginal haemorrhage, menorrhagia, female sexual dysfunction, stress urinary incontinence, chest pain, chest discomfort, heart rate increased, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, diarrhoea, constipation, abdominal distension, umbilical hernia, alopecia, the last episode of fungal infection, migraine, nausea, muscle spasms, blepharospasm, breast inflammation, allergy to metals, depression, mood swings, uterine malposition, vaginal discharge, vision blurred, weight decreased, weight increased, breast pain, abdominal pain lower and back pain outcome was unknown, the headache, arthralgia and pyrexia had resolved and the anxiety, dry skin and rash was resolving.The reporter considered abdominal distension, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, blepharospasm, breast inflammation, breast pain, chest discomfort, chest pain, constipation, depression, diarrhoea, dry skin, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, food allergy, headache, heart rate increased, menorrhagia, migraine, mood swings, muscle spasms, nausea, pain, pelvic pain, pyrexia, rash, stress urinary incontinence, tooth disorder, umbilical hernia, uterine malposition, vaginal discharge, vaginal haemorrhage, vision blurred, weight decreased, weight increased, the first episode of fungal infection and the second episode of fungal infection to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2015: tubes were 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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 1-mar-2018: plaintiff fact sheet received : the product and patient information updated.The event abnormal bleeding (vaginal/menorrhagia), allergic or hypersensitivity reaction; type: certain foods i eat cause stomach pain and hiccups, apareunia (inability to have sexual intercourse), bladder or urinary problems or changes, blood or heart disorder/condition; type: chest pain and tightening, pounding heart beat, dental problems, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, gastrointestinal or digestive system condition; type: diarrhea, constipation, abdominal bloating, issues with umbilical hernia, hair loss, infection (bladder/urinary tract/vaginal); type: yeast infection, migraines/headaches, nausea, neurological conditions or problems; type: muscle spasms in arms and legs, eye twitches, nickel allergy, pain, psychological or psychiatric problems; condition: depression, anxiety mood swings, rashes or skin conditions; type: dry skin, rashes, reproductive system disorder or condition; type of disorder or condition: tilted uterus, yeast infection, surgery (other); type of surgery: tubouterine implantation, bilateral salpingostomy, vaginal discharge, vision/eye problems; type: blurry vision, weight gain/loss; specify which on: both weight loss and weight gain, other injury(ies) or complication(s); please describe: breast pain, inflammation 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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Cutaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") in an adult female patient who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included umbilical hernia.Concurrent conditions included abdominal pain, body mass index normal, hernia and inflammation.On (b)(6)2007, the patient had essure (ess205) inserted.In (b)(6)2007, the patient experienced diarrhoea ("gastrointestinal or digestive system condition; type: diarrhea").In 2008, the patient experienced alopecia ("hair loss/ thinning hair").In 2009, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2010, the patient experienced tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: anxiety"), mood swings ("psychological or psychiatric problems condition: mood swings"), dry skin ("dry skin"), rash ("rashes") and vision blurred ("blurry vision").In 2011, the patient experienced stress urinary incontinence ("bladder or urinary problems or changes : stress incontinence"), chest pain ("blood or heart disorder/condition; type: chest pain"), chest discomfort ("blood or heart disorder/condition; type: tightening"), palpitations ("blood or heart disorder/condition; type: pounding heart beat"), dysmenorrhoea ("dysmenorrhea (cramping)"), breast inflammation ("breast inflammation"), the first episode of fungal infection ("yeast infection"), vaginal discharge ("vaginal discharge") and breast pain ("breast pain").In 2012, the patient experienced fatigue ("fatigue").In 2014, the patient experienced migraine ("migraines"), headache ("headaches"), nausea ("nausea"), muscle spasms ("neurological conditions or problems type: muscle spasms in arms and legs"), weight decreased ("weight loss"), weight increased ("weight gain"), arthralgia ("joints pain"), abdominal pain lower ("abdomen pain") and back pain ("back pain").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), pain ("physical pain/ body pain"), food allergy ("allergic or hypersensitivity reaction; type: certain foods") with hiccups and abdominal pain upper, vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), constipation ("gastrointestinal or digestive system condition; type: constipation"), abdominal distension ("abdominal bloating"), umbilical hernia ("issues with umbilical hernia/many hernia attacks"), the second episode of fungal infection ("infection (bladder/urinary tract/vaginal) type: yeast infection"), blepharospasm ("eye twitches"), uterine malposition ("tilted uterus"), pyrexia ("fevers"), abdominal pain ("abdomen pain"), hormone level abnormal ("hormones are still off but getting better"), immune system disorder ("immune system disorder") and inflammation ("it has caused horrible inflammations.").The patient was treated with surgery (tubouterine implantation, bilateral salpingostomy).Essure (ess205) was removed on (b)(6)2017.At the time of the report, the pelvic pain, pain, food allergy, vaginal haemorrhage, menorrhagia, female sexual dysfunction, stress urinary incontinence, chest pain, chest discomfort, palpitations, tooth disorder, dysmenorrhoea, dyspareunia, fatigue, diarrhoea, constipation, abdominal distension, the last episode of fungal infection, nausea, muscle spasms, blepharospasm, breast inflammation, allergy to metals, mood swings, uterine malposition, vaginal discharge, vision blurred, weight decreased, weight increased, breast pain, abdominal pain lower, back pain, abdominal pain and inflammation outcome was unknown, the umbilical hernia, headache, arthralgia and pyrexia had resolved, the alopecia, depression and immune system disorder had not resolved and the migraine, anxiety, dry skin, rash and hormone level abnormal was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, blepharospasm, breast inflammation, breast pain, chest discomfort, chest pain, constipation, depression, diarrhoea, dry skin, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, food allergy, headache, hormone level abnormal, immune system disorder, inflammation, menorrhagia, migraine, mood swings, muscle spasms, nausea, pain, palpitations, pelvic pain, pyrexia, rash, stress urinary incontinence, tooth disorder, umbilical hernia, uterine malposition, vaginal discharge, vaginal haemorrhage, vision blurred, weight decreased, weight increased, the first episode of fungal infection and the second episode of fungal infection to be related to essure (ess205).Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.3 kg/sqm.Hysterosalpingogram - on (b)(6)2015: tubes were occluded; on (b)(6)2015: tubes were 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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 10-oct-2018: pfs received.Reporter's information added.Events added: abdomen pain, it has caused horrible inflammations,immune system disorder, hormone value changed.Outcome of event issues with umbilical hernia updated from unknown to recovered resolved and migraine, hormone value changed were updated to recovering / resolving and hair loss, depression, immune system disorder to not recovered / not resolved.Concomitant diseases and lab data 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 ("pain") and tooth disorder ("dental problems") in an adult female patient who had essure (ess205) (batch no.624472) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, multiparous ((b)(6) 1995, (b)(6) 1996, (b)(6) 1998/, (b)(6) 1999, (b)(6) 2001, (b)(6) 2003/, (b)(6) 2005, (b)(6) 2009) and itching.Concurrent conditions included abdominal pain, body mass index normal, inflammation, chills, dizziness, bacterial vaginosis, epigastric pain, breast swelling and uterine bleeding.On (b)(6) 2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced diarrhoea ("gastrointestinal or digestive system condition; type: diarrhea"), constipation ("gastrointestinal or digestive system condition; type: constipation"), abdominal distension ("abdominal bloating") and umbilical hernia ("issues with umbilical hernia/many hernia attacks").In 2008, the patient experienced tooth disorder (seriousness criterion medically significant), fatigue ("fatigue"), alopecia ("hair loss/ thinning hair"), allergy to metals ("nickel allergy"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: anxiety"), mood swings ("psychological or psychiatric problems condition: mood swings"), dry skin ("dry skin") and rash ("rashes").In 2009, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vulvovaginal mycotic infection ("infection (bladder/urinary tract/vaginal) type: yeast infection"), breast inflammation ("breast inflammation"), vaginal discharge ("vaginal discharge") and breast pain ("breast pain").In 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), stress urinary incontinence ("bladder or urinary problems or changes : stress incontinence"), chest pain ("blood or heart disorder/condition; type: chest pain"), chest discomfort ("blood or heart disorder/condition; type: tightening"), palpitations ("blood or heart disorder/condition; type: pounding heart beat"), dysmenorrhoea ("dysmenorrhea (cramping)"), muscle spasms ("neurological conditions or problems type: muscle spasms in arms and legs"), blepharospasm ("eye twitches"), vision blurred ("blurry vision") and arthralgia ("joints pain").In 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2013, the patient experienced nausea ("nausea") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").In 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), migraine ("migraines"), headache ("headaches\ head pain"), abdominal pain lower ("abdomen pain") and back pain ("back pain").On an unknown date, the patient experienced pain ("physical pain/ body pain"), food allergy ("allergic or hypersensitivity reaction; type: certain foods") with hiccups and abdominal pain upper, uterine malposition ("tilted uterus"), pyrexia ("fevers"), abdominal pain ("abdomen pain"), immune system disorder ("immune system disorder"), inflammation ("it has caused horrible inflammations.") and hernia pain ("hernia pain") and was found to have hormone level abnormal ("hormones are still off but getting better").The patient was treated with surgery (bilateral salpingostomy and tooth extraction).Essure (ess205) was removed on (b)(6) 2017.At the time of the report, the pelvic pain, pain, food allergy, vaginal haemorrhage, menorrhagia, female sexual dysfunction, stress urinary incontinence, chest pain, chest discomfort, palpitations, tooth disorder, dysmenorrhoea, fatigue, diarrhoea, constipation, abdominal distension, vulvovaginal mycotic infection, nausea, muscle spasms, blepharospasm, breast inflammation, allergy to metals, mood swings, uterine malposition, weight decreased, weight increased, breast pain, abdominal pain lower, back pain, abdominal pain, inflammation and hernia pain outcome was unknown, the dyspareunia, umbilical hernia, migraine, headache, dry skin, vaginal discharge, vision blurred, arthralgia and pyrexia had resolved, the alopecia, depression and immune system disorder had not resolved and the anxiety, rash and hormone level abnormal was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, blepharospasm, breast inflammation, breast pain, chest discomfort, chest pain, constipation, depression, diarrhoea, dry skin, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, food allergy, headache, hernia pain, hormone level abnormal, immune system disorder, inflammation, menorrhagia, migraine, mood swings, muscle spasms, nausea, pain, palpitations, pelvic pain, pyrexia, rash, stress urinary incontinence, tooth disorder, umbilical hernia, uterine malposition, vaginal discharge, vaginal haemorrhage, vision blurred, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).The reporter commented: insertion date provided as (b)(6) 2007 and (b)(6) 2007 diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.3 kg/sqm.Computerised tomogram abdomen - on (b)(6) 2010: bilateral fallopian tube stent devices, otherwise unremarkable ct abdomen and pelvis with contrast.No acute abdominal findings apparent.Hysterosalpingogram - on (b)(6) 2015: tubes were occluded; on (b)(6) 2015: tubes were occluded.Bilateral essure devices are noted with apparent occlusion of the fallopian tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-may-2019: quality safety evaluation of product technical complaint.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-conformant 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 pelvic pain ("pain") and tooth disorder ("dental problems") in an adult female patient who had essure (ess205) (batch no.624472) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included multigravida, multiparous ((b)(6)1995, (b)(6)1996, (b)(6)1998/, (b)(6)1999, (b)(6)2001, (b)(6)2003/,(b)(6)2005, (b)(6)2009) and itching.Concurrent conditions included abdominal pain, body mass index normal, inflammation, chills, dizziness, bacterial vaginosis, epigastric pain, breast swelling and uterine bleeding.On (b)(6)2007, the patient had essure (ess205) inserted.In (b)(6) 2007, the patient experienced diarrhoea ("gastrointestinal or digestive system condition; type: diarrhea"), constipation ("gastrointestinal or digestive system condition; type: constipation"), abdominal distension ("abdominal bloating") and umbilical hernia ("issues with umbilical hernia/many hernia attacks").In 2008, the patient experienced tooth disorder (seriousness criterion medically significant), fatigue ("fatigue"), alopecia ("hair loss/ thining hair"), allergy to metals ("nickel allergy"), depression ("psychological or psychiatric problems condition: depression"), anxiety ("psychological or psychiatric problems condition: anxiety"), mood swings ("psychological or psychiatric problems condition: mood swings"), dry skin ("dry skin") and rash ("rashes").In 2009, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)"), vulvovaginal mycotic infection ("infection (bladder/urinary tract/vaginal) type: yeast infection"), breast inflammation ("breast inflammation"), vaginal discharge ("vaginal discharge") and breast pain ("breast pain").In 2011, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), stress urinary incontinence ("bladder or urinary problems or changes : stress incontinence"), chest pain ("blood or heart disorder/condition; type: chest pain"), chest discomfort ("blood or heart disorder/condition; type: tightening"), palpitations ("blood or heart disorder/condition; type: pounding heart beat"), dysmenorrhoea ("dysmenorrhea (cramping)"), muscle spasms ("neurological conditions or problems type: muscle spasms in arms and legs"), blepharospasm ("eye twitches"), vision blurred ("blurry vision") and arthralgia ("joints pain").In 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)") and menorrhagia ("abnormal bleeding (menorrhagia)").In 2013, the patient experienced nausea ("nausea") and was found to have weight decreased ("weight loss") and weight increased ("weight gain").In 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)"), migraine ("migraines"), headache ("headaches\ head pain"), abdominal pain lower ("abdomen pain") and back pain ("back pain").On an unknown date, the patient experienced pain ("physical pain/ body pain"), food allergy ("allergic or hypersensitivity reaction; type: certain foods") with hiccups and abdominal pain upper, uterine malposition ("tilted uterus"), pyrexia ("fevers"), abdominal pain ("abdomen pain"), immune system disorder ("immune system disorder"), inflammation ("it has caused horrible inflammations.") and hernia pain ("hernia pain") and was found to have hormone level abnormal ("hormones are still off but getting better").The patient was treated with surgery (bilateral salpingostomy and tooth extraction).Essure (ess205) was removed on (b)(6)2017.At the time of the report, the pelvic pain, pain, food allergy, vaginal haemorrhage, menorrhagia, female sexual dysfunction, stress urinary incontinence, chest pain, chest discomfort, palpitations, tooth disorder, dysmenorrhoea, fatigue, diarrhoea, constipation, abdominal distension, vulvovaginal mycotic infection, nausea, muscle spasms, blepharospasm, breast inflammation, allergy to metals, mood swings, uterine malposition, weight decreased, weight increased, breast pain, abdominal pain lower, back pain, abdominal pain, inflammation and hernia pain outcome was unknown, the dyspareunia, umbilical hernia, migraine, headache, dry skin, vaginal discharge, vision blurred, arthralgia and pyrexia had resolved, the alopecia, depression and immune system disorder had not resolved and the anxiety, rash and hormone level abnormal was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, allergy to metals, alopecia, anxiety, arthralgia, back pain, blepharospasm, breast inflammation, breast pain, chest discomfort, chest pain, constipation, depression, diarrhoea, dry skin, dysmenorrhoea, dyspareunia, fatigue, female sexual dysfunction, food allergy, headache, hernia pain, hormone level abnormal, immune system disorder, inflammation, menorrhagia, migraine, mood swings, muscle spasms, nausea, pain, palpitations, pelvic pain, pyrexia, rash, stress urinary incontinence, tooth disorder, umbilical hernia, uterine malposition, vaginal discharge, vaginal haemorrhage, vision blurred, vulvovaginal mycotic infection, weight decreased and weight increased to be related to essure (ess205).The reporter commented: insertion date provided as (b)(6)2007 and (b)(6)2007.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 21.3 kg/sqm.Computerised tomogram abdomen - on (b)(6)2010: bilateral fallopian tube stent devices, otherwise unremarkable ct abdomen and pelvis with contrast.No acute abdominal findings apparent.Hysterosalpingogram - on (b)(6)2015: tubes were occluded; on (b)(6)2015: tubes were occluded.Bilateral essure devices are noted with apparent occlusion of the fallopian tubes.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.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on (b)(6)2019: pfs received: reporters were added.Patient's demographic was added.Lot number was added.Events outcome was updated of migraine, dry skin was updated from recovering \resolving to recovered \resolved.Lab test was updated.Concomitant conditions were added.Event yeast infection clubbed with vaginal yeast infection.New event added:hernia pain 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-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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