| Model Number ESS305 |
| Device Problems
Break (1069); Device Or Device Fragments Location Unknown (2590); Biocompatibility (2886); Device Dislodged or Dislocated (2923)
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| Patient Problems
Abdominal Pain (1685); Fatigue (1849); Hair Loss (1877); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Menstrual Irregularities (1959); Nausea (1970); Neurological Deficit/Dysfunction (1982); Internal Organ Perforation (1987); Perforation (2001); Rash (2033); Urinary Tract Infection (2120); Uterine Perforation (2121); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Cramp(s) (2193); Urticaria (2278); Anxiety (2328); Disability (2371); Obstruction/Occlusion (2422); Abdominal Distention (2601); Weight Changes (2607); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Constipation (3274)
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| Event Date 06/02/2016 |
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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 uterine perforation ("uterine punctures or tears/malposition of essure device (location of device: broken and in the muscle)/perforation (other) (location of the perforation: in the muscle)"), device breakage ("device breakage"), device dislocation ("migration or ¿disappearance¿ of device"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), gastrointestinal injury ("intestinal perforations/obstruction") and intestinal obstruction ("intestinal perforations/obstruction") in a (b)(6) female patient who had essure (batch no.818060) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping);").On (b)(6) 2011, the patient experienced vision blurred ("blurry vision/vision/eye problems (type: vision);") and abdominal distension ("severe bloating").On (b)(6) 2011, the patient experienced fatigue ("fatigue;").In (b)(6)2011, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse);").On (b)(6) 2011, the patient experienced genital haemorrhage (seriousness criteria medically significant).In (b)(6) 2012, the patient experienced anxiety ("psychological or psychiatric problems (condition: anxiety);") and tooth disorder ("dental problems").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, device dislocation, gastrointestinal injury and intestinal obstruction (seriousness criteria medically significant and intervention required), migraine ("migraines"), alopecia ("hair loss/hair loss"), dyspareunia ("pain during sexual intercourse") and weight increased ("weight gain/weight gain;").On an unknown date, the patient experienced device breakage and menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), allergy to metals ("nickel allergy/nickel allergy") with rash generalised, rash, pruritus, urticaria and skin disorder, cystitis ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);"), vaginal infection ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);") with vaginal discharge, hypoaesthesia ("neurological conditions or problems (type: loss of feeling in fingers);"), nausea ("nausea"), constipation ("gastrointestinal or digestive system condition;constipation") and eating disorder ("unable to complete a meal").The patient was treated with surgery (ablation done (b)(6) 2011 balloon dilation and hysteroscopy).Essure treatment was not changed.At the time of the report, the uterine perforation, device breakage, device dislocation, genital haemorrhage, menorrhagia, gastrointestinal injury, intestinal obstruction, migraine, alopecia, dyspareunia, weight increased, vision blurred, vaginal haemorrhage, allergy to metals, cystitis, vaginal infection, female sexual dysfunction, anxiety, hypoaesthesia, nausea, tooth disorder, dysmenorrhoea, constipation, fatigue, eating disorder and abdominal distension outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, anxiety, constipation, cystitis, device breakage, device dislocation, dysmenorrhoea, dyspareunia, eating disorder, fatigue, female sexual dysfunction, gastrointestinal injury, genital haemorrhage, hypoaesthesia, intestinal obstruction, menorrhagia, migraine, nausea, tooth disorder, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: she did not remove essure device.She is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: total bilateral occlusion.On (b)(6) 2016 : ultrasound of pelvic : impression: linear echogenic structures are seen involving both right and left uterine fundus with small adjacent fluid collections these are compatible with preformation of essure devices.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records : uterine perforation.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 events are 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 events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet received: abnormal bleeding (general); abnormal bleeding (vaginal, menorrhagia); allergic or hypersensitivity reaction (type: rash, itching, welts, knots)/ashes or skin conditions (type: rashes all over body), infection (bladder/urinary tract/vaginal) (type: vaginal and bladder); apareunia (inability to have sexual intercourse); psychological or psychiatric problems (condition: anxiety),nausea, dental problems; neurological conditions or problems (type: loss of feeling in fingers), device breakage, dysmenorrhea (cramping); pain; vaginal discharge, fatigue; gastrointestinal or digestive system condition type: constipation, severe bloating, unable to complete a meal.Lot number added.Historical, concomitant condition and relevant lab data were added.On 1-mar-2018: medical records received : reporter information updated.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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Ntaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("uterine punctures or tears/malposition of essure device (location of device: broken and in the muscle)/perforation (other) (location of the perforation: in the muscle)"), device breakage ("device breakage"), device dislocation ("migration or ¿disappearance¿ of device"), genital haemorrhage ("abnormal bleeding (general)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia);"), gastrointestinal injury ("intestinal perforations/obstruction") and intestinal obstruction ("intestinal perforations/obstruction") in a 42-year-old female patient who had essure (batch no.818060 (invalid)) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for anxiety: xanax.Concomitant products included alprazolam, alprazolam (xanax) and ibuprofen (advil).On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping);").On (b)(6) 2011, the patient experienced alopecia ("hair loss/hair loss"), weight increased ("weight gain/weight gain;"), vision blurred ("blurry vision/vision/eye problems (type: vision);"), cystitis ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);"), vaginal infection ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);") with vaginal discharge and abdominal distension ("severe bloating").On (b)(6) 2011, the patient experienced fatigue ("fatigue;").In july 2011, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse);").On (b)(6) 2011, the patient experienced genital haemorrhage (seriousness criterion medically significant).In january 2012, the patient experienced anxiety ("psychological or psychiatric problems (condition: anxiety);") and tooth disorder ("dental problems").On (b)(6) 2016 the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, device dislocation (seriousness criteria medically significant and intervention required), gastrointestinal injury (seriousness criterion medically significant), intestinal obstruction (seriousness criterion medically significant), migraine ("migraines") and dyspareunia ("pain during sexual intercourse").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), allergy to metals ("nickel allergy/nickel allergy") with rash generalised, dermatitis allergic, pruritus allergic, urticaria and skin disorder, hypoaesthesia ("neurological conditions or problems (type: loss of feeling in fingers);"), nausea ("nausea"), constipation ("gastrointestinal or digestive system condition;constipation") and early satiety ("unable to complete a meal").The patient was treated with surgery, (ablation done (b)(6) 2011 balloon dilation and hysteroscopy).Essure treatment was not changed.At the time of the report, the uterine perforation, device breakage, device dislocation, genital haemorrhage, menorrhagia, gastrointestinal injury, intestinal obstruction, migraine, alopecia, dyspareunia, weight increased, vision blurred, vaginal haemorrhage, allergy to metals, cystitis, vaginal infection, female sexual dysfunction, anxiety, hypoaesthesia, nausea, tooth disorder, dysmenorrhoea, constipation, fatigue, early satiety and abdominal distension outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, anxiety, constipation, cystitis, device breakage, device dislocation, dysmenorrhoea, dyspareunia, early satiety, fatigue, female sexual dysfunction, gastrointestinal injury, genital haemorrhage, hypoaesthesia, intestinal obstruction, menorrhagia, migraine, nausea, tooth disorder, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: she did not remove essure device.She is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on 23-sep-2011: total bilateral occlusion.On 12-jul-2016 : ultrasound of pelvic : impression: linear echogenic structures are seen involving both right and left uterine fundus with small adjacent fluid collections these are compatible with preformation of essure devices.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records : uterine perforation.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 events are 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 events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 13-aug-2018: quality-safety evaluation of ptc (product technical complaint) 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 uterine perforation ('uterine punctures or tears/malposition of essure device (location of device: broken and in the muscle)/perforation (other) (location of the perforation: in the muscle)'), device breakage ('device breakage'), device dislocation ('migration or ¿disappearance¿ of device'), menorrhagia ('abnormal bleeding (vaginal, menorrhagia);'), gastrointestinal injury ('intestinal perforations/obstruction') and intestinal obstruction ('intestinal perforations/obstruction') in a 42-year-old female patient who had essure (batch no.818060 inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: on (b)(6) 2016 : ultrasound of pelvic : impression: linear echogenic structures are seen involving both right and left uterine fundus with small adjacent fluid collections these are compatible with preformation of essure devices.Previously administered products included for anxiety: xanax.Concomitant products included alprazolam (xanax) for anxiety as well as alprazolam and ibuprofen.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping);").On (b)(6) 2011, the patient experienced alopecia ("hair loss/hair loss"), vision blurred ("blurry vision/vision/eye problems (type: vision);"), cystitis ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);"), vaginal infection ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);") with vaginal discharge, anaesthesia ("neurological conditions or problems (type: loss of feeling in fingers);"), nausea ("nausea") and abdominal distension ("severe bloating") and was found to have weight increased ("weight gain/weight gain;").On (b)(6) 2011, the patient experienced fatigue ("fatigue;").In (b)(6) 2011, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse);").On (b)(6) 2011, the patient experienced genital haemorrhage ("abnormal bleeding (general)").In (b)(6) 2012, the patient experienced anxiety ("psychological or psychiatric problems (condition: anxiety);") and tooth disorder ("dental problems").On (b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, device dislocation (seriousness criteria medically significant and intervention required), gastrointestinal injury (seriousness criterion medically significant), intestinal obstruction (seriousness criterion medically significant), migraine ("migraines") and dyspareunia ("pain during sexual intercourse").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), allergy to metals ("nickel allergy/nickel allergy") with rash, dermatitis allergic, pruritus allergic, urticaria and skin disorder, constipation ("gastrointestinal or digestive system condition;constipation") and early satiety ("unable to complete a meal").The patient was treated with surgery (ablation done (b)(6) 2011 balloon dilation and hysteroscopy).Essure was removed.At the time of the report, the uterine perforation, device breakage, device dislocation, menorrhagia, gastrointestinal injury, intestinal obstruction, genital haemorrhage, migraine, alopecia, dyspareunia, weight increased, vision blurred, vaginal haemorrhage, allergy to metals, cystitis, vaginal infection, female sexual dysfunction, anxiety, anaesthesia, nausea, tooth disorder, dysmenorrhoea, constipation, fatigue, early satiety and abdominal distension outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, anaesthesia, anxiety, constipation, cystitis, device breakage, device dislocation, dysmenorrhoea, dyspareunia, early satiety, fatigue, female sexual dysfunction, gastrointestinal injury, genital haemorrhage, intestinal obstruction, menorrhagia, migraine, nausea, tooth disorder, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: she did not remove essure device.She is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records : uterine perforation.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 events are 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 events cannot be totally excluded.Most recent follow-up information incorporated above includes: on 9-sep-2020: ppf received: essure device removed.Incident based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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 uterine perforation ('uterine punctures or tears/malposition of essure device (location of device: broken and in the muscle)/perforation (other) (location of the perforation: in the muscle)'), device breakage ('device breakage'), device dislocation ('migration or ¿disappearance¿ of device'), menorrhagia ('abnormal bleeding (vaginal, menorrhagia);'), gastrointestinal injury ('intestinal perforations/obstruction') and intestinal obstruction ('intestinal perforations/obstruction') in a 42-year-old female patient who had essure (batch no.818060 inv) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Medical conditions: on (b)(6) 2016 : ultrasound of pelvic : impression: linear echogenic structures are seen involving both right and left uterine fundus with small adjacent fluid collections these are compatible with preformation of essure devices.Previously administered products included for anxiety: xanax.Concomitant products included alprazolam (xanax) for anxiety as well as alprazolam and ibuprofen.On (b)(6) 2011, the patient had essure inserted.On (b)(6) 2011, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping);").On (b)(6) 2011, the patient experienced alopecia ("hair loss/hair loss"), vision blurred ("blurry vision/vision/eye problems (type: vision);"), cystitis ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);"), vaginal infection ("infection (bladder/urinary tract/vaginal) (type: vaginal and bladder);") with vaginal discharge, anaesthesia ("neurological conditions or problems (type: loss of feeling in fingers);"), nausea ("nausea") and abdominal distension ("severe bloating") and was found to have weight increased ("weight gain/weight gain;").On (b)(6) 2011, the patient experienced fatigue ("fatigue;").In (b)(6) 2011, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse);").On (b)(6) 2011, the patient experienced genital haemorrhage ("abnormal bleeding (general)").In (b)(6) 2012, the patient experienced anxiety ("psychological or psychiatric problems (condition: anxiety);") and tooth disorder ("dental problems").(b)(6) 2016, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, device dislocation (seriousness criteria medically significant and intervention required), gastrointestinal injury (seriousness criterion medically significant), intestinal obstruction (seriousness criterion medically significant), migraine ("migraines") and dyspareunia ("pain during sexual intercourse").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia);"), allergy to metals ("nickel allergy/nickel allergy") with rash, dermatitis allergic, pruritus allergic, urticaria and skin disorder, constipation ("gastrointestinal or digestive system condition;constipation") and early satiety ("unable to complete a meal").The patient was treated with surgery (ablation done (b)(6) 2011 balloon dilation and hysteroscopy).Essure was removed.At the time of the report, the uterine perforation, device breakage, device dislocation, menorrhagia, gastrointestinal injury, intestinal obstruction, genital haemorrhage, migraine, alopecia, dyspareunia, weight increased, vision blurred, vaginal haemorrhage, allergy to metals, cystitis, vaginal infection, female sexual dysfunction, anxiety, anaesthesia, nausea, tooth disorder, dysmenorrhoea, constipation, fatigue, early satiety and abdominal distension outcome was unknown.The reporter considered abdominal distension, allergy to metals, alopecia, anaesthesia, anxiety, constipation, cystitis, device breakage, device dislocation, dysmenorrhoea, dyspareunia, early satiety, fatigue, female sexual dysfunction, gastrointestinal injury, genital haemorrhage, intestinal obstruction, menorrhagia, migraine, nausea, tooth disorder, uterine perforation, vaginal haemorrhage, vaginal infection, vision blurred and weight increased to be related to essure.The reporter commented: she did not remove essure device.She is currently planning for essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: results: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records : uterine perforation.Lot number 818060 reported is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-sep-2020: quality-safety evaluation of ptc(product technical complaint).Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.
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