| Model Number ESS305 |
| Device Problems
Break (1069); Detachment Of Device Component (1104); Migration (4003)
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| Patient Problems
Adhesion(s) (1695); Pain (1994); Pelvic Inflammatory Disease (2000); Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 01/01/2016 |
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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 pelvic pain ("chronic pelvic pain") and device breakage ("small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy.") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.In (b)(6) 2013, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criterion medically significant), complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of inetal causes issues it will need to be removed during a hysterectomy."), pelvic adhesions ("lysis of adhesion") and biopsy peritoneum ("peritonial biopsy").The patient was treated with surgery (on (b)(6) 2016, plantiff underwent a laproscopic salpingectomy, lysis of adhesion, peritonial biopsy).At the time of the report, the pelvic pain, device breakage, complication of device removal, pelvic adhesions and biopsy peritoneum outcome was unknown.The reporter considered complication of device removal, device breakage, pelvic adhesions and pelvic pain to be related to essure.The reporter provided no causality assessment for biopsy peritoneum with essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Diagnostic results: (b)(6) 2014: hysterosalpingogram - confirmed satisfactory placement and full occlusion of both tubes.Company causality comment: 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 ("perforation (uterus)/migration of essure device location of device: portruding out of the cornua"), device breakage ("small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy"), pelvic pain ("chronic pelvic pain") and pelvic adhesions ("lysis of adhesion") in a 41-year-old female patient who had essure (batch no.A50513) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for contraception: mirena in 2013 and nuvaring from 2009 to 2010.Past adverse reactions to the above products included adverse drug reaction with mirena.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced anxiety ("anxiety").In (b)(6) 2016, the patient experienced nausea ("nausea").In (b)(6) 2016, the patient experienced vertigo ("vertigo").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criteria medically significant and intervention required), biopsy peritoneum ("peritonital biopsy") and complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy.").The patient was treated with surgery (on (b)(6) 2016, plaintiff underwent a laproscopic salpingectomy, lysis of adhesion, peritonial biopsy).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device breakage, pelvic adhesions, biopsy peritoneum, complication of device removal and vertigo outcome was unknown and the pelvic pain, anxiety, nausea and dysmenorrhoea had resolved.The reporter provided no causality assessment for biopsy peritoneum with essure.The reporter considered anxiety, complication of device removal, device breakage, dysmenorrhoea, nausea, pelvic adhesions, pelvic pain, uterine perforation and vertigo to be related to essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Diagnostic results: (b)(6) 2014: hysterosalpingogram - confirmed satisfactory placement and full occlusion of both tubes.On (b)(6) 2016, post-op x-ray revealed portion of essure device was still visible on the left fallopian tube and not able to be removed from the uterus.Transabdominal and transvaginal examinations revealed displacement of the endometrial complex by a small amount of fluid.Within this region, there is an oval-shaped area of increased echogenicity measuring 5 mm, differential considerations include but not limited to an endometrial polyp or echogenic clot.If sono hysterography or hysteroscopy and tissue sampling is not performed, consideration should be given to short-term interval follow-up ultrasound immediately after menses in the next 2 cycles, 2.Echogenic linear focus at the junction of the fundus of the uterus and fallopian tube may reflect an essure device.Clinical correlation is recommended, no similar finding is seen in the contralateral aspect of the right fundus/fallopian tube junction.On (b)(6) 2016, ultrasound revealed the left coil is in place.The right coil is identified in the pelvis.However, it is oriented in a more vertical position than on hysterosalpingogram.There is also a radiopaque 2.0 x 0.5 mm reticular density, just medial and unattached to the more caudal aspect of the right coil.Possible migration or perforation cannot be excluded.Repeat hysterosalpingogram is suggested, as clinically indicated.On (b)(6) 2016, previous radiographs have demonstrated adjacent possible broken off piece in the right pelvis.Confirm no retained foreign body concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, device breakage, uterine perforation and anxiety.Most recent follow-up information incorporated above includes: on (b)(6) 2018: this case is medically confirmed.Reporter information was added.This case concerns 41 year old patient.Her demographic was added.Her historical medication was added.Lab data was added.Essure lot number was added.Essure insertion and removal date was updated.Essure indication was amended.Following events: perforation (uterus)/migration of essure device location of device: protruding out of the cornua, small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy, anxiety, nausea, dysmenorrhea (cramping)and vertigo were added.She had recovered from following events: pelvic pain, dysmenorrhea, nausea and anxiety.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 salpingitis ("salpingitis"), uterine perforation ("perforation (uterus)/migration of essure device location of device: portruding out of the cornua"), device breakage ("small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy"), pelvic pain ("chronic pelvic pain") and pelvic adhesions ("lysis of adhesion") in a 41-year-old female patient who had essure (batch no.A50513) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included dysuria, amenorrhea, vaginitis bacterial, fatigue, anemia, female sexual dysfunction, alopecia areata, miscarriage, cholecystectomy in 1997 and vaginal candidiasis.Previously administered products included for contraception: mirena in 2013 and nuvaring from 2009 to 2010; for decreased libido: testosterone; for recurrent bv: clindamycin; for an unreported indication: augmentin and mirena.Past adverse reactions to the above products included adverse drug reaction with mirena; and rash with augmentin.Concurrent conditions included paratubal cyst and hematuria.Concomitant products included ibuprofen for back pain, ibuprofen (motrin) for flank pain as well as colestipol since 2014.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced anxiety ("anxiety").In (b)(6) 2016, the patient experienced nausea ("nausea").In (b)(6) 2016, the patient experienced vertigo ("vertigo").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criteria medically significant and intervention required) and complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of inetal causes issues it will need to be removed during a hysterectomy.") and was found to have biopsy peritoneum ("peritonial biopsy").The patient was treated with surgery (on (b)(6) 2016, she underwent a laparoscopic salpingectomy, lysis of adhesion, peritoneal biopsy).Essure was removed.At the time of the report, the salpingitis, uterine perforation, device breakage, pelvic adhesions, biopsy peritoneum, complication of device removal and vertigo outcome was unknown and the pelvic pain, anxiety, nausea and dysmenorrhoea had resolved.The reporter provided no causality assessment for biopsy peritoneum and salpingitis with essure.The reporter considered anxiety, complication of device removal, device breakage, dysmenorrhoea, nausea, pelvic adhesions, pelvic pain, uterine perforation and vertigo to be related to essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Per medical record: pathology report: right fallopian tube: salpingitis, calcifications and foreign body type reaction and paratubal cyst.Essure coil in fallopian tube (gross diagnosis.).Essure coil from left fallopian tube (gross diagnosis).Left fallopian tube: - salpingitis with calcifications and foreign body type reaction.Peritoneal biopsy: chronic inflammatory changes.Insertion details: left and right ostia visualized.Left: number of coils ¿ 1 right: number of coils: 3.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on an unknown date: adjacent possible broken off piece in the right pelvis.Confirm no retained foreign body; on (b)(6) 2016: left coil is in place.The right coil is identified in the pelvis.However, it is oriented in a more vertical position than on hysterosalpingogram.There is also a radiopaque 2.0 x 0.5 mm reticular density, just medial and unattached to the more caudal aspect of the right coil.Possible migration or perforation cannot be excluded.Repeat hysterosalpingogram is suggested, as clinically indicated.X-ray - on (b)(6) 2016: result: portion of essure device was still visible on the left fallopian tube and not able to be removed from the uterus.Transabdominal and transvaginal examinations revealed displacement of the endometrial complex by a small amount of fluid.Within this region, there is an oval-shaped area of increased echogenicity measuring 5 mm, differential considerations include but not limited to an endometrial polyp or echogenic clot.If sono hysterography or hysteroscopy and tissue sampling is not performed, consideration should be given to short-term interval follow-up ultrasound immediately after menses in the next 2 cycles, 2.Echogenic linear focus at the junction of the fundus of the uterus and fallopian tube may reflect an essure device.Clinical correlation is recommended, no similar finding is seen in the contralateral aspect of the right fundus/fallopian tube junction; on (b)(6) 2017: reviewed x ray unchanged from previous x ray; still retained piece on left.Concerning the injuries reported in this case, the following ones were described in patients medical record: salpingitis, pelvic pain, device breakage, uterine perforation and anxiety.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 11-jan-2019: reporter information was added.Her demographic was added.Drug allergy was added.Her historical medication/condition and concurrent conditions were added.Lab data was added.Her concomitant medications were added.Per medical record event: salpingitis was added.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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Manufacturer Narrative
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Contaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("perforation (uterus)/migration of essure device location of device: protruding out of the cornua"), device breakage ("small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy"), pelvic pain ("chronic pelvic pain") and pelvic adhesions ("lysis of adhesion") in a 41-year-old female patient who had essure (batch no.A50513) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for contraception: mirena in 2013 and nuvaring from 2009 to 2010.Past adverse reactions to the above products included adverse drug reaction with mirena.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced anxiety ("anxiety").In (b)(6) 2016, the patient experienced nausea ("nausea").In (b)(6) 2016, the patient experienced vertigo ("vertigo").On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criteria medically significant and intervention required), biopsy peritoneum ("peritonital biopsy") and complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of intal causes issues it will need to be removed during a hysterectomy.").The patient was treated with surgery (on (b)(6) 2016, plaintiff underwent a laparoscopic salpingectomy, lysis of adhesion, peritonital biopsy), surgery (on (b)(6) 2016, plaintiff underwent a laparoscopic salpingectomy, lysis of adhesion, peritonital biopsy) and surgery (on (b)(6) 2016, plaintiff underwent a laparoscopic salpingectomy, lysis of adhesion, peritonital biopsy).Essure was removed on (b)(6) 2016.At the time of the report, the uterine perforation, device breakage, pelvic adhesions, biopsy peritoneum, complication of device removal and vertigo outcome was unknown and the pelvic pain, anxiety, nausea and dysmenorrhoea had resolved.The reporter provided no causality assessment for biopsy peritoneum with essure.The reporter considered anxiety, complication of device removal, device breakage, dysmenorrhoea, nausea, pelvic adhesions, pelvic pain, uterine perforation and vertigo to be related to essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Diagnostic results: (b)(6) 2014: hysterosalpingogram - confirmed satisfactory placement and full occlusion of both tubes.On (b)(6) 2016, post-op x-ray revealed portion of essure device was still visible on the left fallopian tube and not able to be removed from the uterus.Transabdominal and transvaginal examinations revealed displacement of the endometrial complex by a small amount of fluid.Within this region, there is an oval-shaped area of increased echogenicity measuring 5 mm, differential considerations include but not limited to an endometrial polyp or echogenic clot.If sono hysterography or hysteroscopy and tissue sampling is not performed, consideration should be given to short-term interval follow-up ultrasound immediately after menses in the next 2 cycles, 2.Echogenic linear focus at the junction of the fundus of the uterus and fallopian tube may reflect an essure device.Clinical correlation is recommended, no similar finding is seen in the contralateral aspect of the right fundus/fallopian tube junction.On (b)(6) 2016, ultrasound revealed the left coil is in place.The right coil is identified in the pelvis.However, it is oriented in a more vertical position than on hysterosalpingogram.There is also a radiopaque 2.0 x 0.5 mm reticular density, just medial and unattached to the more caudal aspect of the right coil.Possible migration or perforation cannot be excluded.Repeat hysterosalpingogram is suggested, as clinically indicated.On (b)(6) 2016, previous radiographs have demonstrated adjacent possible broken off piece in the right pelvis.Confirm no retained foreign body concerning the injuries reported in this case, the following ones were described in patients medical record: pelvic pain, device breakage, uterine perforation and anxiety.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality-safety evaluation of product technical problem update.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 salpingitis ('salpingitis'), uterine perforation ('perforation (uterus)/migration of essure device location of device: portruding out of the cornua'), device breakage ('small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy/small piece of left essure coil is still here'), pelvic pain ('chronic pelvic pain') and pelvic adhesions ('lysis of adhesion') in a 41-year-old female patient who had essure (batch no.A50513, a50613) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 1997, dysuria, amenorrhea, vaginitis bacterial, fatigue, anemia, female sexual dysfunction, alopecia areata, miscarriage, vaginal candidiasis, right lower quadrant pain, diarrhea, bowel movement irregularity, swelling of tongue, gastric disorder, jaw operation, fibroids, adhesion, salpingitis, candida infection, jaw operation, pain in elbow, hair loss, alopecia areata, neoplasm skin, vaginal discharge, contact dermatitis, sinusitis, premature delivery, vaginal delivery, cholecystectomy, seborrheic keratosis, concussion, jaw fracture, vertigo, low back pain, sleep disorder and ovarian cyst ruptured.Denies weight loss, but has difficulty gaining weight.Denies reflux, heartburn, odynophagia.Dysphagia, pain, blood in stool.Previously administered products included for contraception: mirena in 2013 and nuvaring from 2009 to 2010; for decreased libido: testosterone; for recurrent bv: clindamycin; for an unreported indication: augmentin and mirena.Past adverse reactions to the above products included adverse drug reaction with mirena; and rash with augmentin.Concurrent conditions included paratubal cyst, hematuria, pelvic congestion syndrome, vertigo, vestibular neuronitis, bppv, sialolithiasis, vitamin d deficiency, dizziness, acute pharyngitis, hypoglycemia, lymphedema, streptococcal sore throat, fever, major depressive disorder, depressive disorder, low back pain, hair loss, abdominal pain, raynaud's disease, post concussion syndrome, environmental allergy, chilblains, sinusitis recurrent, atopic, allergic rhinitis, allergic to cats, sinus operation, depression, peripheral swelling, low back pain, tenderness, vaginal itching, yeast infection, irritation skin, burning sensation, discomfort, vaginal odor and spotting vaginal.Concomitant products included ibuprofen for back pain, ibuprofen (motrin) for flank pain as well as colestipol since 2014.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced anxiety ("anxiety").In (b)(6) 016, the patient experienced nausea ("nausea").In (b)(6) 2016, the patient experienced vertigo ("vertigo").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criteria medically significant and intervention required) and complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of inetal causes issues it will need to be removed during a hysterectomy.") and was found to have biopsy peritoneum ("peritonial biopsy").The patient was treated with surgery (on (b)(6) 2016, she underwent a laparoscopic salpingectomy, lysis of adhesion, peritoneal biopsy).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, uterine perforation, device breakage, pelvic adhesions, biopsy peritoneum, complication of device removal and vertigo outcome was unknown and the pelvic pain, anxiety, nausea and dysmenorrhoea had resolved.The reporter provided no causality assessment for biopsy peritoneum and salpingitis with essure.The reporter considered anxiety, complication of device removal, device breakage, dysmenorrhoea, nausea, pelvic adhesions, pelvic pain, uterine perforation and vertigo to be related to essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Per medical record: pathology report: right fallopian tube: salpingitis, calcifications and foreign body type reaction and paratubal cyst.Essure coil in fallopian tube (gross diagnosis.).Essure coil from left fallopian tube (gross diagnosis).Left fallopian tube: - salpingitis with calcifications and foreign body type reaction.Peritoneal biopsy: chronic inflammatory changes.Insertion details: left and right ostia visualized.Left: number of coils ¿ 1 right: number of coils: 3.Salpingoopherectomy, bilateral hx of (removal of essure coils).Plaintiff said that she has "a piece left over." medical records :-with right lower quadrant pain.Sip bilateral salpingectomies for broken essure coil on right side.Known piece of remaining collin the uterine cornea.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: results: confirmed satisfactory placement and full occlusio; on (b)(6) 2016: unable to see right coil with ultrasound and possible abnormal orientation of the right coil seen on plain film.Ultrasound pelvis - on an unknown date: adjacent possible broken off piece in the right pelvis.Confirm no retained foreign body; on (b)(6) 2016: left coil is in place.The right coil is identified in the pelvis.However, it is oriented in a more vertical position than on hysterosalpingogram.There is also a radiopaque 2.0 x 0.5 mm reticular density, just medial and unattached to the more caudal aspect of the right coil.Possible migration or perforation cannot be excluded.Repeat hysterosalpingogram is suggested, as clinically indicated.Ultrasound scan - on (b)(6) 2016: result: endometrial polyp on ultrasound with irregular spotting.X-ray - on (b)(6) 2016: result: portion of essure device was still visible on the left fallopian tube and not able to be removed from the uterus.Transabdominal and transvaginal examinations revealed displacement of the endometrial complex by a small amount of fluid.Within this region, there is an oval-shaped area of increased echogenicity measuring 5 mm, differential considerations include but not limited to an endometrial polyp or echogenic clot.If sono hysterography or hysteroscopy and tissue sampling is not performed, consideration should be given to short-term interval follow-up ultrasound immediately after menses in the next 2 cycles, 2.Echogenic linear focus at the junction of the fundus of the uterus and fallopian tube may reflect an essure device.Clinical correlation is recommended, no similar finding is seen in the contralateral aspect of the right fundus/fallopian tube junction; on (b)(6) 2016: small piece of left essure coil is still here.; on (b)(6) 2016: x-ray above and below point of injury with obvious deformity; 3 views as minimum and supplement as needed.There is no joint effusion, acute fracture or dislocation.No acute skeletal abnormality.; on (b)(6) 2017: reviewed x ray unchanged from previous x ray; still retained piece on left.Concerning the injuries reported in this case, the following ones were described in patients medical record: salpingitis, pelvic pain, device breakage, uterine perforation, anxiety, fatigue,generalized anxiety disorder most recent follow-up information incorporated above includes: on 15-oct-2019: mr received : lot number added.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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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of salpingitis ('salpingitis'), uterine perforation ('perforation (uterus)/migration of essure device location of device: portruding out of the cornua'), device breakage ('small coil like piece of metal was found in the right lower quadrant area, if this piece of metal causes issues it will need to be removed during a hysterectomy/small piece of left essure coil is still here'), pelvic pain ('chronic pelvic pain') and pelvic adhesions ('lysis of adhesion') in a 41-year-old female patient who had essure (batch no.A50513, a50613-not valid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included cholecystectomy in 1997, dysuria, amenorrhea, vaginitis bacterial, fatigue, anemia, female sexual dysfunction, alopecia areata, miscarriage, vaginal candidiasis, right lower quadrant pain, diarrhea, bowel movement irregularity, swelling of tongue, gastric disorder, jaw operation, fibroids, adhesion, salpingitis, candida infection, jaw operation, pain in elbow, hair loss, alopecia areata, neoplasm skin, vaginal discharge, contact dermatitis, sinusitis, premature delivery, vaginal delivery, cholecystectomy, seborrheic keratosis, concussion, jaw fracture, vertigo, low back pain, sleep disorder and ovarian cyst ruptured.Denies weight loss, but has difficulty gaining weight.Denies reflux, heartburn, odynophagia.Dysphagia, pain, blood in stool.Previously administered products included for contraception: mirena in 2013 and nuvaring from 2009 to 2010; for decreased libido: testosterone; for recurrent bv: clindamycin; for an unreported indication: augmentin and mirena.Past adverse reactions to the above products included adverse drug reaction with mirena; and rash with augmentin.Concurrent conditions included paratubal cyst, hematuria, pelvic congestion syndrome, vertigo, vestibular neuronitis, bppv, sialolithiasis, vitamin d deficiency, dizziness, acute pharyngitis, hypoglycemia, lymphedema, streptococcal sore throat, fever, major depressive disorder, depressive disorder, low back pain, hair loss, abdominal pain, raynaud's disease, post concussion syndrome, environmental allergy, chilblains, sinusitis recurrent, atopic, allergic rhinitis, allergic to cats, sinus operation, depression, peripheral swelling, low back pain, tenderness, vaginal itching, yeast infection, irritation skin, burning sensation, discomfort, vaginal odor and spotting vaginal.Concomitant products included ibuprofen for back pain, ibuprofen (motrin) for flank pain as well as colestipol since 2014.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2016, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and dysmenorrhoea ("dysmenorrhea (cramping)").In (b)(6) 2016, the patient experienced anxiety ("anxiety").In (b)(6) 2016, the patient experienced nausea ("nausea").In (b)(6) 2016, the patient experienced vertigo ("vertigo").On an unknown date, the patient experienced salpingitis (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criteria medically significant and intervention required) and complication of device removal ("small coil like piece of metal was found in the right lower quadrant area, if this piece of inetal causes issues it will need to be removed during a hysterectomy.") and was found to have biopsy peritoneum ("peritonial biopsy").The patient was treated with surgery (on (b)(6) 2016, she underwent a laparoscopic salpingectomy, lysis of adhesion, peritoneal biopsy).Essure was removed on (b)(6) 2016.At the time of the report, the salpingitis, uterine perforation, device breakage, pelvic adhesions, biopsy peritoneum, complication of device removal and vertigo outcome was unknown and the pelvic pain, anxiety, nausea and dysmenorrhoea had resolved.The reporter provided no causality assessment for biopsy peritoneum and salpingitis with essure.The reporter considered anxiety, complication of device removal, device breakage, dysmenorrhoea, nausea, pelvic adhesions, pelvic pain, uterine perforation and vertigo to be related to essure.The reporter commented: plaintiff was informed that if this piece of metal causes issues it will need to be removed during a hysterectomy.Per medical record: pathology report: right fallopian tube: salpingitis, calcifications and foreign body type reaction and paratubal cyst.Essure coil in fallopian tube (gross diagnosis.).Essure coil from left fallopian tube (gross diagnosis).Left fallopian tube: - salpingitis with calcifications and foreign body type reaction.Peritoneal biopsy: chronic inflammatory changes.Insertion details: left and right ostia visualized.Left: number of coils ¿ 1 right: number of coils: 3.Salpingoopherectomy, bilateral hx of (removal of essure coils).Plaintiff said that she has "a piece left over." medical records :-with right lower quadrant pain.Sip bilateral salpingectomies for broken essure coil on right side.Known piece of remaining collin the uterine cornea.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2014: results: confirmed satisfactory placement and full occlusio; on (b)(6) 2016: unable to see right coil with ultrasound and possible abnormal orientation of the right coil seen on plain film.Ultrasound pelvis - on an unknown date: adjacent possible broken off piece in the right pelvis.Confirm no retained foreign body; on (b)(6) 2016: left coil is in place.The right coil is identified in the pelvis.However, it is oriented in a more vertical position than on hysterosalpingogram.There is also a radiopaque 2.0 x 0.5 mm reticular density, just medial and unattached to the more caudal aspect of the right coil.Possible migration or perforation cannot be excluded.Repeat hysterosalpingogram is suggested, as clinically indicated.Ultrasound scan - on (b)(6) 2016: result: endometrial polyp on ultrasound with irregular spotting.X-ray - on (b)(6) 2016: result: portion of essure device was still visible on the left fallopian tube and not able to be removed from the uterus.Transabdominal and transvaginal examinations revealed displacement of the endometrial complex by a small amount of fluid.Within this region, there is an oval-shaped area of increased echogenicity measuring 5 mm, differential considerations include but not limited to an endometrial polyp or echogenic clot.If sono hysterography or hysteroscopy and tissue sampling is not performed, consideration should be given to short-term interval follow-up ultrasound immediately after menses in the next 2 cycles, 2.Echogenic linear focus at the junction of the fundus of the uterus and fallopian tube may reflect an essure device.Clinical correlation is recommended, no similar finding is seen in the contralateral aspect of the right fundus/fallopian tube junction; on (b)(6) 2016: small piece of left essure coil is still here.; on (b)(6) 2016: x-ray above and below point of injury with obvious deformity; 3 views as minimum and supplement as needed.There is no joint effusion, acute fracture or dislocation.No acute skeletal abnormality.; on (b)(6) 2017: reviewed x ray unchanged from previous x ray; still retained piece on left.Concerning the injuries reported in this case, the following ones were described in patients medical record: salpingitis, pelvic pain, device breakage, uterine perforation, anxiety, fatigue,generalized anxiety disorder the lot number reported (a50613) is not valid.Most recent follow-up information incorporated above includes: on 5-nov-2019: update of information (batch is not valid).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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