| Model Number ESS305 |
| Device Problems
Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Hyperplasia (1906); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Viral Infection (2248); Discomfort (2330)
|
| Event Date 04/01/2014 |
|
Event Type
Injury
|
|
Event Description
|
|
This case was initially received via regulatory authority fda division director (reference number: mw5032565) on 13-jan-2014.The most recent information was received on 22-nov-2017.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain \ pelvic region pain"), genital haemorrhage ("heavy bleeding with large clots"), adenomyosis ("adenomyosis") and endometrial hyperplasia ("atypical complex endometrial hyperplasia") in a (b)(6) female patient who had essure (batch no.731586) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficulty in right insertion had to use 2nd essure".The patient's past medical history included gravida ii, miscarriage (2), type 2 diabetes mellitus from 2004 to 2014, essential hypertension and cholecystectomy.Patient having no history of cancer.Patient does not had dysuria, urinary frequency , urinary urgency , urinary incontinence, hot flashes, night sweats.Libido not decrease.Concurrent conditions included allergic rhinitis, viral infection, penicillin allergy, allergic reaction to antibiotics, acute sinusitis, hyperglycemia and obesity.Concomitant products included norethisterone acetate (norethindrone acetate) in (b)(6) 2014 for menorrhagia, metformin for type 2 diabetes mellitus as well as ibuprofen, ketorolac, oral contraceptive nos, oxycodone, triobe (foltx [cyanocobalamin,folic acid andpyridoxine]).In 2011, 97 days before insertion of essure, the patient experienced genital haemorrhage (seriousness criterion medically significant), menstrual disorder ("abnormal periods"), dysmenorrhoea ("periods with abdominal pain / dysmenorrhea") and allergy to metals ("nickel allergy / after the device was placed in 2011, i noticed my nickel allergy was worse/hypersensitivity reaction to nickel") with rash erythematous and skin exfoliation.On an unknown date, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("lower abdomen pain").On (b)(6) 2014, the patient experienced menorrhagia ("menorrhagia").On (b)(6) 2014, the patient experienced adenomyosis (seriousness criterion medically significant) and endometrial hyperplasia (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal discomfort ("abdominal discomfort"), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea"), fatigue ("severe fatigue"), headache ("headaches"), cervicitis ("focal acute cervicitis"), localised oedema ("ear edema"), ear pain ("ear pain"), mental disorder ("essure caused or aggravated any psychiatric and/or psychological condition") and investigation noncompliance ("patient did not undergo essure confirmation test").The patient was treated with surgery (underwent hysterectomy and bilateral salpingectomy), surgery (hysterectomy) and surgery (hysterectomy).Essure was removed.On (b)(6) 2014, the dysmenorrhoea and menorrhagia had resolved.At the time of the report, the pelvic pain, genital haemorrhage, adenomyosis, endometrial hyperplasia, abdominal discomfort, nausea, vomiting, diarrhoea, fatigue, headache, cervicitis, abdominal pain lower, allergy to metals, localised oedema, ear pain, mental disorder and investigation noncompliance outcome was unknown and the menstrual disorder had not resolved.The reporter considered abdominal pain lower, adenomyosis, allergy to metals, cervicitis, ear pain, endometrial hyperplasia, genital haemorrhage, investigation noncompliance, localised oedema, menorrhagia, mental disorder and pelvic pain to be related to essure.The reporter provided no causality assessment for abdominal discomfort, diarrhoea, dysmenorrhoea, fatigue, headache, menstrual disorder, nausea and vomiting with essure.The reporter commented: patient had cystoscopy, on-q pain pump placement diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on an unknown date: amenorrhea.Patient had surgical pathology reports on (b)(6) 2014 which resulted in endometrial biopsy for menorrhagia: crowded glands with secretory change representing at least a complex hyperplasia with extensive stromal breakdown.Most recent follow-up information incorporated above includes: on 22-nov-2017: case upgraded to incident.Reporter, patient´s historical condition, drugs, concomitant condition and lab data were added.Dob updated.Essure lot number added.Events added: pelvic pain, menorrhagia, adenomyosis, focal acute cervicitis, atypical complex endometrial hyperplasia, lower abdomen pain, nickel allergy, essure caused/aggravated any psychiatric and/or psychological condition, difficulty in right insertion had to use 2nd essure, she did not undergo essure confirmation test, finger under ring became red/ scaly/ itchy, ear edema and pain.Essure legal manufacturer has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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.
|
| |
|
Manufacturer Narrative
|
|
This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain \ pelvic region pain"), genital haemorrhage ("heavy bleeding with large clots"), adenomyosis ("adenomyosis") and endometrial hyperplasia ("atypical complex endometrial hyperplasia") in a 35-year-old female patient who had essure (batch no.731586) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficulty in right insertion had to use 2nd essure".The patient's past medical history included gravida ii, miscarriage (2), type 2 diabetes mellitus from (b)(6) to (b)(6), essential hypertension and cholecystectomy.Patient having no history of cancer.Patient does not had dysuria, urinary frequency , urinary urgency , urinary incontinence, hot flashes, night sweats.Libido not decrease.Concurrent conditions included allergic rhinitis, viral infection, penicillin allergy, allergic reaction to antibiotics, acute sinusitis, hyperglycemia and obesity.Concomitant products included norethisterone acetate (norethindrone acetate) since (b)(6) 2014 for menorrhagia, metformin for type 2 diabetes mellitus as well as ibuprofen, ketorolac, oral contraceptive nos, oxycodone and triobe (foltx [cyanocobalamin,folic acid,pyridoxine]).On an unknown date, the patient had essure inserted.In (b)(6), the patient experienced genital haemorrhage (seriousness criterion medically significant), menstrual disorder ("abnormal periods"), dysmenorrhoea ("periods with abdominal pain / dysmenorrhea") and allergy to metals ("nickel allergy / after the device was placed in (b)(6), i noticed my nickel allergy was worse/hypersensitivity reaction to nickel") with rash erythematous and skin exfoliation.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("lower abdomen pain").On (b)(6) 2014, 2 years 8 months after insertion of essure, the patient experienced menorrhagia ("menorrhagia").On (b)(6) 2014, the patient experienced adenomyosis and endometrial hyperplasia (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal discomfort ("abdominal discomfort"), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea"), fatigue ("severe fatigue"), headache ("headaches"), cervicitis ("focal acute cervicitis"), localised oedema ("ear edema"), ear pain ("ear pain"), mental disorder ("essure caused or aggravated any psychiatric and/or psychological condition") and investigation noncompliance ("patient did not undergo essure confirmation test").The patient was treated with surgery (underwent hysterectomy and bilateral salpingectomy).Essure was removed.On (b)(6) 2014, the dysmenorrhoea and menorrhagia had resolved.At the time of the report, the pelvic pain, genital haemorrhage, adenomyosis, endometrial hyperplasia, abdominal discomfort, nausea, vomiting, diarrhoea, fatigue, headache, cervicitis, abdominal pain lower, allergy to metals, localised oedema, ear pain, mental disorder and investigation noncompliance outcome was unknown and the menstrual disorder had not resolved.The reporter provided no causality assessment for abdominal discomfort, diarrhoea, dysmenorrhoea, fatigue, headache, menstrual disorder, nausea and vomiting with essure.The reporter considered abdominal pain lower, adenomyosis, allergy to metals, cervicitis, ear pain, endometrial hyperplasia, genital haemorrhage, investigation noncompliance, localised oedema, menorrhagia, mental disorder and pelvic pain to be related to essure.The reporter commented: patient had cystoscopy, on-q pain pump placement diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on an unknown date: amenorrhea patient had surgical pathology reports on (b)(6) 2014 which resulted in endometrial biopsy for menorrhagia: crowded glands with secretory change representing at least a complex hyperplasia with extensive stromal breakdown most recent follow-up information incorporated above includes: on 15-jun-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.
|
| |
|
Manufacturer Narrative
|
|
Ntaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain \ pelvic region pain"), genital haemorrhage ("heavy bleeding with large clots"), adenomyosis ("adenomyosis") and endometrial hyperplasia ("atypical complex endometrial hyperplasia") in a 35-year-old female patient who had essure (batch no.731586) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "difficulty in right insertion had to use 2nd essure".The patient's past medical history included gravida ii, miscarriage (2), type 2 diabetes mellitus from 2004 to 2014, essential hypertension and cholecystectomy.Patient having no history of cancer.Patient does not had dysuria, urinary frequency , urinary urgency , urinary incontinence, hot flashes, night sweats.Libido not decrease.Concurrent conditions included allergic rhinitis, viral infection, penicillin allergy, allergic reaction to antibiotics, acute sinusitis, hyperglycemia and obesity.Concomitant products included norethisterone acetate (norethindrone acetate) since (b)(6) 2014 for menorrhagia, metformin for type 2 diabetes mellitus as well as ibuprofen, ketorolac, oral contraceptive nos, oxycodone and triobe (foltx [cyanocobalamin,folic acid,pyridoxine]).In 2011, the patient experienced genital haemorrhage (seriousness criterion medically significant), menstrual disorder ("abnormal periods"), dysmenorrhoea ("periods with abdominal pain / dysmenorrhea") and allergy to metals ("nickel allergy / after the device was placed in 2011, i noticed my nickel allergy was worse/hypersensitivity reaction to nickel") with rash erythematous and skin exfoliation.On an unknown date, the patient had essure inserted.In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and abdominal pain lower ("lower abdomen pain").On (b)(6) 2014, 2 years 8 months after insertion of essure, the patient experienced menorrhagia ("menorrhagia").On (b)(6) 2014, the patient experienced adenomyosis (seriousness criterion medically significant) and endometrial hyperplasia (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal discomfort ("abdominal discomfort"), nausea ("nausea"), vomiting ("vomiting"), diarrhoea ("diarrhea"), fatigue ("severe fatigue"), headache ("headaches"), cervicitis ("focal acute cervicitis"), localised oedema ("ear edema"), ear pain ("ear pain"), mental disorder ("essure caused or aggravated any psychiatric and/or psychological condition"), investigation noncompliance ("patient did not undergo essure confirmtion test") and hot flush ("hot flashes").The patient was treated with surgery (undewent hysterectomy and bilateral salpingectomy), surgery (hysterectomy) and surgery (hysterectomy).Essure was removed.On (b)(6) 2014, the dysmenorrhoea and menorrhagia had resolved.At the time of the report, the pelvic pain, genital haemorrhage, adenomyosis, endometrial hyperplasia, abdominal discomfort, nausea, vomiting, diarrhoea, fatigue, headache, cervicitis, abdominal pain lower, allergy to metals, localised oedema, ear pain, mental disorder, investigation noncompliance and hot flush outcome was unknown and the menstrual disorder had not resolved.The reporter provided no causality assessment for abdominal discomfort, diarrhoea, dysmenorrhoea, fatigue, headache, menstrual disorder, nausea and vomiting with essure.The reporter considered abdominal pain lower, adenomyosis, allergy to metals, cervicitis, ear pain, endometrial hyperplasia, genital haemorrhage, hot flush, investigation noncompliance, localised oedema, menorrhagia, mental disorder and pelvic pain to be related to essure.The reporter commented: patient had cystoscopy, on-q pain pump placement diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on an unknown date: amenorrhea patient had surgical pathology reports on (b)(6) 2014 which resulted in endometrial biopsy for menorrhagia: crowded glands with secretory change representing at least a complex hyperplasia with extensive stromal breakdown.Concerning the injuries reported in this case, the following one was reported via social media: hot flush.Most recent follow-up information incorporated above includes: on 25-jun-2018: social media post: new event: hot flush, reporter 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.
|
| |
|
Search Alerts/Recalls
|
|
