| Model Number ESS305 |
| Device Problems
Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Abdominal Pain (1685); Arrhythmia (1721); Autoimmune Reaction (1733); Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Muscle Weakness (1967); Pain (1994); Rash (2033); Tinnitus (2103); Tingling (2171); Arthralgia (2355); Numbness (2415); Abdominal Distention (2601)
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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 abdominal pain lower (abdominal pain/cramping), genital haemorrhage ("heavy bleeding") in a female patient who had essure (ess205) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included nickel sensitivity.Patient had no previous history of migraine.In (b)(6) 2002, the patient had essure (ess205) inserted.On an unknown date, the patient experienced menstrual, abdominal and back pain, cramping and bloating, irregular and prolonged menstruation, heavy bleeding / easy bleeding, fatigue, weight gain, vision changes, dental problems, earaches, ringing in ears, sinus problems, mouth sores, hearing problems, chest pain, irregular heart beats, shortness of breath, frequent diarrhea, urgency to urinate, frequent urination, rashes, skin dryness, sores, numbness or tingling, memory difficulties, frequent headaches, joint pain, muscle pain, muscular weakness, loss of hair, cold intolerance, heat intolerance, easy bruising, and frequent illness.Essure (ess205) was removed.Patient had no choice but to undergo a hysterectomy to have her essure removed.At the time of the report, the events outcome was unknown.The reporter considered all reported adverse events to be related to essure (ess205).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 abdominal pain lower ("abdominal pain/ cramping", seriousness criteria intervention required), dysmenorrhea ("severe menstrual pain", seriousness criteria intervention required) and (genital haemorrhage ("heavy bleeding", seriousness criteria medically significant) in a female patient who had essure (lot number a14898) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's concurrent conditions included nickel sensitivity, gravida 4, parity 3 ((b)(6)).Patient had no previous history of migraine.In (b)(6) 2012, the patient had essure (ess305) inserted.On an unknown date, the patient experienced menstrual, abdominal and back pain, cramping and bloating, irregular and prolonged menstruation, heavy bleeding / easy bleeding, fatigue, weight gain, vision changes, dental problems, earaches, ringing in ears, sinus problems, mouth sores, hearing problems, chest pain, irregular heart beats, shortness of breath, frequent diarrhea, urgency to urinate, frequent urination, rashes, skin dryness, sores, numbness or tingling, memory difficulties, frequent headaches, joint pain, muscle pain, muscular weakness, loss of hair, cold intolerance, heat intolerance, easy bruising, frequent illness, vaginal bleeding, vaginal pain, lips and face would swell for no reason, allergic to nickel, she did not undergo essure confirmation test and stomach cramps.Essure (ess305) was removed on (b)(6) 2017.Patient underwent to a partial hysterectomy to have her essure removed.Plaintiff states that once the essure device was removed she felt 100% better.She has not experienced any symptoms post partial hysterectomy.The reporter considered all reported adverse events to be related to essure (ess205).Most recent follow-up information incorporated above includes: on 8-jan-2018: new events added: vaginal bleeding, vaginal pain, lips and face would swell for no reason, allergic to nickel, she did not undergo essure confirmation test, stomach cramps.Lot number was provided.Date of essure implantation was updated (essure 205 updated to ess 305.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 abdominal pain lower ("cramping/abdominal pain"), genital haemorrhage ("heavy bleeding / easy bleeding/ excess bleeding") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.A14898) 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 did not undergo essure confirmation test.".The patient's past medical history included nickel sensitivity, multigravida, parity 3 ((b)(6) 2012, (b)(6) 2007 and (b)(6) 2003), menarche (15 years old), abortion and loop electrosurgical excision procedure.Patient had no previous history of migraine before essure insertion.Concurrent conditions included vulval itching, vulval irritation, vulvovaginitis, allergy, gastric disorder, stomach pain, irregular menstrual cycle and gerd.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced vulvovaginal pain ("vaginal pain").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain") (seriousness criterion intervention required), back pain ("back pain"), abdominal distension ("bloating/swelling"), menometrorrhagia ("irregular and prolonged menstruation"), migraine ("severe migraines"), fatigue ("fatigue"), weight increased ("weight gain"), visual impairment ("vision changes"), tooth disorder ("dental problems"), ear pain ("earaches"), tinnitus ("ringing in ears"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), heart rate irregular ("irregular heart beats"), dyspnoea ("shortness of breath"), diarrhoea ("frequent diarrhea"), micturition urgency ("urgency to urinate"), pollakiuria ("frequent urination"), rash generalised ("rashes/ rashes on her body"), dry skin ("skin dryness"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain"), muscular weakness ("muscular weakness"), alopecia ("loss of hair"), temperature intolerance ("cold intolerance and heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), vaginal haemorrhage ("vaginal bleeding"), lip swelling ("lips and face would swell for no reason"), swelling face ("lips and face would swell for no reason"), allergy to metals ("allergic to nickel") and abdominal pain upper ("stomach cramps").The patient was treated with surgery (she had partial hysterectomy/hysterectomy vaginal to have essure removed) and surgery (partial hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, back pain, menometrorrhagia, migraine, fatigue, rash generalised, hypoaesthesia, vaginal haemorrhage, vulvovaginal pain, lip swelling, swelling face, allergy to metals and abdominal pain upper had resolved and the uterine haemorrhage, abdominal distension, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, dry skin, paraesthesia, memory impairment, headache, arthralgia, muscular weakness, alopecia, temperature intolerance, increased tendency to bruise and malaise outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, auditory disorder, back pain, chest pain, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, lip swelling, malaise, memory impairment, menometrorrhagia, micturition urgency, migraine, muscular weakness, paraesthesia, pollakiuria, rash generalised, sinus disorder, stomatitis, swelling face, temperature intolerance, tinnitus, tooth disorder, uterine haemorrhage, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: plaintiff states that once the essure device was removed she felt 100% better.She has not experienced any symptoms post partial hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.On (b)(6) 2017, surgical report showed, boggy 90 gm uterus with normal ovaries.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: "uterine haemorrhage " (confirming genital haemorrhage), abdominal pain upper.Most recent follow-up information incorporated above includes: medical record received - new event "abnormal uterine bleeding" was added.New reporters - other health professional - were added.Historical and concomitant conditions 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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This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ("cramping/abdominal pain"), genital haemorrhage ("heavy bleeding / easy bleeding/ excess bleeding") and uterine haemorrhage ("abnormal uterine bleeding") in an adult female patient who had essure (batch no.A14898) 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 did not undergo essure confirmation test.".The patient's past medical history included nickel sensitivity, multigravida, parity 3 (b)(6) 2012, (b)(6) 2007 and (b)(6) 2003, menarche (15 years old), abortion and loop electrosurgical excision procedure.Patient had no previous history of migraine before essure insertion.Concurrent conditions included vulval itching, vulval irritation, vulvovaginitis, allergy, gastric disorder, stomach pain, irregular menstrual cycle and gerd.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced vulvovaginal pain ("vaginal pain").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), dysmenorrhoea ("severe menstrual pain") (seriousness criterion intervention required), back pain ("back pain"), abdominal distension ("bloating/swelling"), menometrorrhagia ("irregular and prolonged menstruation"), migraine ("severe migraines"), fatigue ("fatigue"), weight increased ("weight gain"), visual impairment ("vision changes"), tooth disorder ("dental problems"), ear pain ("earaches"), tinnitus ("ringing in ears"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), heart rate irregular ("irregular heart beats"), dyspnoea ("shortness of breath"), diarrhoea ("frequent diarrhea"), micturition urgency ("urgency to urinate"), pollakiuria ("frequent urination"), rash generalised ("rashes/ rashes on her body"), dry skin ("skin dryness"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain"), muscular weakness ("muscular weakness"), alopecia ("loss of hair"), temperature intolerance ("cold intolerance and heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), vaginal haemorrhage ("vaginal bleeding"), lip swelling ("lips and face would swell for no reason"), swelling face ("lips and face would swell for no reason"), allergy to metals ("allergic to nickel") and abdominal pain upper ("stomach cramps").The patient was treated with surgery (she had partial hysterectomy/hysterectomy vaginal to have essure removed) and surgery (partial hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, back pain, menometrorrhagia, migraine, fatigue, rash generalised, hypoaesthesia, vaginal haemorrhage, vulvovaginal pain, lip swelling, swelling face, allergy to metals and abdominal pain upper had resolved and the uterine haemorrhage, abdominal distension, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, dry skin, paraesthesia, memory impairment, headache, arthralgia, muscular weakness, alopecia, temperature intolerance, increased tendency to bruise and malaise outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, auditory disorder, back pain, chest pain, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, lip swelling, malaise, memory impairment, menometrorrhagia, micturition urgency, migraine, muscular weakness, paraesthesia, pollakiuria, rash generalised, sinus disorder, stomatitis, swelling face, temperature intolerance, tinnitus, tooth disorder, uterine haemorrhage, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: plaintiff states that once the essure device was removed she felt 100% better.She has not experienced any symptoms post partial hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.On (b)(6) 2017, surgical report showed, boggy 90 gm uterus with normal ovaries.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: "uterine haemorrhage " (confirming genital haemorrhage), abdominal pain upper.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 27-jun-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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This spontaneous case was reported by a lawyer and describes the occurrence of abdominal pain lower ('cramping/abdominal pain') in an adult female patient who had essure (batch no.A14898) 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 did not undergo essure confirmation test.".The patient's medical history included nickel sensitivity, multigravida, parity 3 (b)(6) 2012, (b)(6) 2007 and (b)(6) 2003)), menarche (15 years old), abortion and loop electrosurgical excision procedure.Patient had no previous history of migraine before essure insertion.Concurrent conditions included vulval itching, vulval irritation, vulvovaginitis, allergy, gastric disorder, stomach pain, irregular menstrual cycle and gerd.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy bleeding / easy bleeding/ excess bleeding, unusual bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), dysmenorrhoea ("severe menstrual pain"), back pain ("back pain"), abdominal distension ("bloating/swelling"), menometrorrhagia ("irregular and prolonged menstruation"), migraine ("severe migraines"), fatigue ("fatigue"), visual impairment ("vision changes"), tooth disorder ("dental problems"), ear pain ("earaches"), tinnitus ("ringing in ears"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), dyspnoea ("shortness of breath"), diarrhoea ("frequent diarrhea"), micturition urgency ("urgency to urinate"), pollakiuria ("frequent urination"), rash ("rashes/ rashes on her body"), dry skin ("skin dryness"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain"), muscular weakness ("muscular weakness"), alopecia ("loss of hair"), temperature intolerance ("cold intolerance and heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), vaginal haemorrhage ("vaginal bleeding"), vulvovaginal pain ("vaginal pain"), lip swelling ("lips and face would swell for no reason"), swelling face ("lips and face would swell for no reason"), allergy to metals ("allergic to nickel"), abdominal pain upper ("stomach cramps") and menstrual disorder ("unusual period") and was found to have weight increased ("weight gain") and heart rate irregular ("irregular heart beats").The patient was treated with surgery (she had partial hysterectomy/hysterectomy vaginal to have essure removed).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, back pain, menometrorrhagia, migraine, fatigue, rash, hypoaesthesia, vaginal haemorrhage, vulvovaginal pain, lip swelling, swelling face, allergy to metals and abdominal pain upper had resolved and the uterine haemorrhage, abdominal distension, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, dry skin, paraesthesia, memory impairment, headache, arthralgia, muscular weakness, alopecia, temperature intolerance, increased tendency to bruise, malaise and menstrual disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, auditory disorder, back pain, chest pain, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, lip swelling, malaise, memory impairment, menometrorrhagia, menstrual disorder, micturition urgency, migraine, muscular weakness, paraesthesia, pollakiuria, rash, sinus disorder, stomatitis, swelling face, temperature intolerance, tinnitus, tooth disorder, uterine haemorrhage, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: plaintiff states that once the essure device was removed she felt 100% better.She has not experienced any symptoms post partial hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.On (b)(6) 2017, surgical report showed, boggy 90 gm uterus with normal ovaries.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: "uterine haemorrhage " (confirming genital haemorrhage), abdominal pain upper, migraine, back pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 26-oct-2020: quality-safety evaluation of ptc (product technical complaint).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 abdominal pain lower ('cramping/abdominal pain') in an adult female patient who had essure (batch no.A14898) 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 did not undergo essure confirmation test.".The patient's medical history included nickel sensitivity, multigravida, parity 3 (b)(6) 2012, (b)(6) 2007 and (b)(6) 2003)), menarche (15 years old), abortion and loop electrosurgical excision procedure.Patient had no previous history of migraine before essure insertion.Concurrent conditions included vulval itching, vulval irritation, vulvovaginitis, allergy, gastric disorder, stomach pain, irregular menstrual cycle and gerd.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), genital haemorrhage ("heavy bleeding / easy bleeding/ excess bleeding, unusual bleeding"), uterine haemorrhage ("abnormal uterine bleeding"), dysmenorrhoea ("severe menstrual pain"), back pain ("back pain"), abdominal distension ("bloating/swelling"), menometrorrhagia ("irregular and prolonged menstruation"), migraine ("severe migraines"), fatigue ("fatigue"), visual impairment ("vision changes"), tooth disorder ("dental problems"), ear pain ("earaches"), tinnitus ("ringing in ears"), sinus disorder ("sinus problems"), stomatitis ("mouth sores"), auditory disorder ("hearing problems"), chest pain ("chest pain"), dyspnoea ("shortness of breath"), diarrhoea ("frequent diarrhea"), micturition urgency ("urgency to urinate"), pollakiuria ("frequent urination"), rash ("rashes/ rashes on her body"), dry skin ("skin dryness"), hypoaesthesia ("numbness"), paraesthesia ("tingling"), memory impairment ("memory difficulties"), headache ("frequent headaches"), arthralgia ("joint pain"), muscular weakness ("muscular weakness"), alopecia ("loss of hair"), temperature intolerance ("cold intolerance and heat intolerance"), increased tendency to bruise ("easy bruising"), malaise ("frequent illness"), vaginal haemorrhage ("vaginal bleeding"), vulvovaginal pain ("vaginal pain"), lip swelling ("lips and face would swell for no reason"), swelling face ("lips and face would swell for no reason"), allergy to metals ("allergic to nickel"), abdominal pain upper ("stomach cramps") and menstrual disorder ("unusual period") and was found to have weight increased ("weight gain") and heart rate irregular ("irregular heart beats").The patient was treated with surgery (she had partial hysterectomy/hysterectomy vaginal to have essure removed).Essure was removed on (b)(6) 2017.At the time of the report, the abdominal pain lower, genital haemorrhage, dysmenorrhoea, back pain, menometrorrhagia, migraine, fatigue, rash, hypoaesthesia, vaginal haemorrhage, vulvovaginal pain, lip swelling, swelling face, allergy to metals and abdominal pain upper had resolved and the uterine haemorrhage, abdominal distension, weight increased, visual impairment, tooth disorder, ear pain, tinnitus, sinus disorder, stomatitis, auditory disorder, chest pain, heart rate irregular, dyspnoea, diarrhoea, micturition urgency, pollakiuria, dry skin, paraesthesia, memory impairment, headache, arthralgia, muscular weakness, alopecia, temperature intolerance, increased tendency to bruise, malaise and menstrual disorder outcome was unknown.The reporter considered abdominal distension, abdominal pain lower, abdominal pain upper, allergy to metals, alopecia, arthralgia, auditory disorder, back pain, chest pain, diarrhoea, dry skin, dysmenorrhoea, dyspnoea, ear pain, fatigue, genital haemorrhage, headache, heart rate irregular, hypoaesthesia, increased tendency to bruise, lip swelling, malaise, memory impairment, menometrorrhagia, menstrual disorder, micturition urgency, migraine, muscular weakness, paraesthesia, pollakiuria, rash, sinus disorder, stomatitis, swelling face, temperature intolerance, tinnitus, tooth disorder, uterine haemorrhage, vaginal haemorrhage, visual impairment, vulvovaginal pain and weight increased to be related to essure.The reporter commented: plaintiff states that once the essure device was removed she felt 100% better.She has not experienced any symptoms post partial hysterectomy.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.2 kg/sqm.On (b)(6) 2017, surgical report showed, boggy 90 gm uterus with normal ovaries.Concerning the injuries reported in this case, the following one was described in patient¿s medical records: "uterine haemorrhage " (confirming genital haemorrhage), abdominal pain upper, migraine, back pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-oct-2020: pif received event unusual period" was 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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