MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Biocompatibility (2886); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 11/10/2019

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of abdominal pain ("abdominal pain") and device breakage ("essure fragments") in a 39 year-old female patient who had essure inserted (lot no.A33563) for female sterilization.Additional non-serious events are detailed below.The patient had a medical history of smoker, small intestine gangrene and tachycardia.Concomitant products included amoxicillin for upper respiratory tract infection, cefuroxime for swelling, paracetamol /pseudoefedrina sulfato /dextrometorfano hidrobromuro farm (paracetamol + pseudoephedrine + dextromethorphan) for headache and neck pain, desogestrel, avamys (fluticasone furoate), cetirizina (cetirex) (cetirizine hydrochloride) for pelvic inflammatory disease and ibuprofen for pelvic pain.On (b)(6) 2013, the patient had essure inserted.On (b)(6) 2013, the day of essure insertion, she experienced malaise ("malaise"), temperature regulation disorder ("dysthermic sensation"), abdominal distension ("abdominal swelling"), iliac fossa pain ("pain in the illac fossae"), menstrual disorder ("menstrual disorder"), headache ("headache") and pruritus ("skin itching").On (b)(6) 2014 she experienced pain in hip ("hip pain").On (b)(6) 2014 she experienced sinusitis ("sinusitis").On (b)(6) 2015 she experienced upper respiratory tract infection ("upper respiratory tract infection").On (b)(6) 2015 she experienced genital candidiasis ("genital candidiasis").On (b)(6) 2015 she experienced vertigo ("post chordactomy infection").On (b)(6) 2015 she experienced muscle contracture ("muscle ontacture").On (b)(6) 2016 she experienced uterine cervical pain ("cervix pain").On (b)(6) 2016 she experienced dermatitis ("dermatitis").On (b)(6) 2016 she experienced rhinorrhoea ("runny nose").On (b)(6) 2016 she experienced dyspnoea ("dyspnea") and odynophagia ("odynophagia").On (b)(6) 2017 she experienced laryngitis ("laryngitis").On (b)(6) 2018 she experienced pyrexia ("fever").On (b)(6)2018 she experienced diarrhoea ("diarrhea").On (b)(6) 2019 she experienced vaginal discharge ("increased nonsmellyvaginal discharge").On (b)(6) 2019 she experienced chest discomfort ("chest discomfort"), cough ("cough") and vomiting ("vomiting").On (b)(6) 2019 she experienced intermenstrual bleeding ("metrorrhagia") and hypogastric pain ("hypogastric pain").On (b)(6) 2019 she experienced skin lesion ("skin lesion"), hypersensitivity ("hypersensitivity") and sneezing ("sneezing in burst").On (b)(6) 2019 she experienced pelvic pain ("pelvic pain female").On (b)(6) 2019 she experienced tooth infection ("dental infection").On (b)(6) 2019 she experienced abdominal pain (seriousness criterion intervention required) and vaginal bleeding ("vaginal bleeding").On (b)(6) 2019 she experienced nausea ("nausea").On (b)(6) 2020 she experienced abdominal discomfort ("abdominal discomfort"), rash ("body rash"), neck pain ("neck pain"), groin pain ("groin injury") and dermal cyst ("trichermal cyst").On (b)(6) 2020 she experienced constipation ("constipation"), spotting vaginal ("light spotting for month"), a first episode of anxiety ("anxiety") and insomnia ("insomnia").On (b)(6) 2020 she experienced arthromyalgia ("athromyalgia").On (b)(6) 2021 she experienced dizziness ("dizziness"), disturbance in attention ("concentration") and a second episode of anxiety ("anxiety").On (b)(6) 2021 she experienced burning sensation ("burning sensation all over").On (b)(6) 2021 she experienced rectal haemorrhage ("rectal bleeding") and fatigue ("tired").On (b)(6) 2021 she experienced erythema ("erythema at the pre auricular level, skin"), skin tightness ("skin tightness") and hives ("hives on the forehead on the right arm elbow").On (b)(6) 2021 she experienced seborrhoeic dermatitis ("seborrheic dermatitis"), onychomycosis ("nail mycosis"), keloid scar ("keloid scar") and urticaria ("urticaria").An unknown time later she experienced device breakage (seriousness criterion intervention required), haematochezia ("blood stool") and nasal congestion ("nasal congestion").The patient was treated with surgery (on (b)(6) 2019 bilateral salpingectomy and on (b)(6) 2020 hysterectomy).At the time of the report, the outcomes for abdominal pain, malaise, temperature regulation disorder, abdominal distension, iliac fossa pain, menstrual disorder, headache, pruritus, vaginal bleeding, diarrhoea, vaginal discharge, intermenstrual bleeding, hypogastric pain, pelvic pain, abdominal discomfort, rash, neck pain, groin pain, dermal cyst, constipation, spotting vaginal, insomnia, skin lesion, hypersensitivity, sneezing, seborrhoeic dermatitis, onychomycosis, keloid scar, urticaria, erythema, skin tightness, hives, rectal haemorrhage, fatigue, burning sensation, arthromyalgia, dizziness, disturbance in attention, haematochezia, tooth infection, chest discomfort, cough, vomiting, nausea, pyrexia, laryngitis, dyspnoea, odynophagia, nasal congestion, rhinorrhoea, dermatitis, uterine cervical pain, muscle contracture, genital candidiasis, upper respiratory tract infection, sinusitis, vertigo, pain in hip and the last episode of anxiety were unknown.The reporter considered abdominal discomfort, abdominal distension, abdominal pain, iliac fossa pain, hypogastric pain, the first episode of anxiety, the second episode of anxiety, pain in hip, arthromyalgia, burning sensation, chest discomfort, constipation, cough, dermal cyst, dermatitis, device breakage, diarrhoea, disturbance in attention, dizziness, dyspnoea, erythema, fatigue, genital candidiasis, groin pain, haematochezia, headache, hypersensitivity, insomnia, intermenstrual bleeding, keloid scar, laryngitis, malaise, menstrual disorder, muscle contracture, nasal congestion, nausea, neck pain, odynophagia, onychomycosis, pelvic pain, pruritus, pyrexia, rash, rectal haemorrhage, rhinorrhoea, seborrhoeic dermatitis, sinusitis, skin lesion, skin tightness, sneezing, temperature regulation disorder, tooth infection, upper respiratory tract infection, hives, urticaria, uterine cervical pain, vaginal discharge, vaginal bleeding, spotting vaginal, vertigo and vomiting to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on (b)(6) 2020: remains of the essure device.[defecography] on (b)(6) 2019: uterus in rvf with 10 mm endometrium.Normal right ovary.Normal left ovary.No free liquid.[full blood count] on (b)(6) 2019: 32.2; on (b)(6) 2020: leukocytes 12.17 x10 ^9/l.Lymphocytes 12.1%.Neutrophils 81.8 %.Neutrophils 9.96 x10^9/l.[pathology test] on (b)(6) 2020: essure fragments (20b-26275): fibrous tissue with minimal inflammatory.Changes.Essure type device is identified.2- uterus (20b-26276): cervix: squamous metaplasia.Endometrium with multiple areas of vascular proliferation, suggestive of endometrial polyps.Essure device fragment persistence after bilateral salpingectomy.Sample type: uterus.Procedure: hysterectomy.Total samples 2 uteru.Quality-safety evaluation of ptc: for essure: unable to confirm complaint.The most recent follow-up information incorporated above includes data received on: 24-nov-2023: new events abdominal pain, malaise, temperature regulation disorder, abdominal distension, iliac fossa pain, menstrual disorder, headache, pruritus, vaginal bleeding, diarrhoea, vaginal discharge, intermenstrual bleeding, hypogastric pain, pelvic pain, abdominal discomfort, rash, neck pain, groin pain, dermal cyst, constipation, spotting vaginal, insomnia, skin lesion, hypersensitivity, sneezing, seborrhoeic dermatitis, onychomycosis, keloid scar, urticaria, erythema, skin tightness, hives, rectal haemorrhage, fatigue, burning sensation, arthromyalgia, dizziness, disturbance in attention, haematochezia, tooth infection, chest discomfort, cough, vomiting, nausea, pyrexia, laryngitis, dyspnoea, odynophagia, nasal congestion, rhinorrhoea, dermatitis, uterine cervical pain, muscle contracture, genital candidiasis, upper respiratory tract infection, sinusitis, vertigo, pain in hip anxiety are added.Product indication start stop date added.Medical history , concomitant drugs & lab data updated.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of abdominal pain ("abdominal pain") and device breakage ("essure fragments") in a 39 year-old female patient who had essure inserted (lot no.A33563) for permanent contraceptive tubal implant.Additional non-serious events are detailed below.The patient had a medical history of smoker, small intestine gangrene and tachycardia.Concomitant products included amoxicillin;clavulanic acid for upper respiratory tract infection, cefuroxime for swelling, paracetamol;pseudoephedrine, desogestrel, avamys (fluticasone furoate), cetirizina (cetirex) (cetirizine hydrochloride) for pelvic inflammatory disease and ibuprofen for pelvic pain.On 24-may-2013, the patient had essure inserted.On 24-may-2013, the day of essure insertion, she experienced malaise ("malaise"), temperature regulation disorder ("dysthermic sensation"), abdominal distension ("abdominal swelling"), iliac fossa pain ("pain in the illac fossae"), menstrual disorder ("menstrual disorder"), headache ("headache") and pruritus ("skin itching").On 30-jun-2014 she experienced pain in hip ("hip pain").On 27-oct-2014 she experienced sinusitis ("sinusitis").On 28-sep-2015 she experienced upper respiratory tract infection ("upper respiratory tract infection").On 02-oct-2015 she experienced genital candidiasis ("genital candidiasis").On 04-nov-2015 she experienced vertigo ("post chordactomy infection").On 07-dec-2015 she experienced muscle contracture ("muscle ontacture").On 18-jan-2016 she experienced uterine cervical pain ("cervix pain").On 11-feb-2016 she experienced dermatitis ("dermatitis").On 08-mar-2016 she experienced rhinorrhoea ("runny nose").On 30-jul-2016 she experienced dyspnoea ("dyspnea") and odynophagia ("odynophagia").On 21-feb-2017 she experienced laryngitis ("laryngitis").On 27-jan-2018 she experienced pyrexia ("fever").On 22-dec-2018 she experienced diarrhoea ("diarrhea").On 12-apr-2019 she experienced vaginal discharge ("increased nonsmellyvaginal discharge").On 01-may-2019 she experienced chest discomfort ("chest discomfort"), cough ("cough") and vomiting ("vomiting").On 30-may-2019 she experienced intermenstrual bleeding ("metrorrhagia") and hypogastric pain ("hypogastric pain").On 22-aug-2019 she experienced skin lesion ("skin lesion"), hypersensitivity ("hypersensitivity") and sneezing ("sneezing in burst").On 29-aug-2019 she experienced pelvic pain ("pelvic pain female").On 12-oct-2019 she experienced tooth infection ("dental infection").On 10-nov-2019 she experienced abdominal pain (seriousness criterion intervention required) and vaginal bleeding ("vaginal bleeding").On 20-dec-2019 she experienced nausea ("nausea").On 17-jan-2020 she experienced abdominal discomfort ("abdominal discomfort"), rash ("body rash"), neck pain ("neck pain"), groin pain ("groin injury") and dermal cyst ("trichermal cyst").On 01-oct-2020 she experienced constipation ("constipation"), spotting vaginal ("light spotting for month"), a first episode of anxiety ("anxiety") and insomnia ("insomnia").On 13-oct-2020 she experienced arthromyalgia ("athromyalgia").On 13-may-2021 she experienced dizziness ("dizziness"), disturbance in attention ("concentration") and a second episode of anxiety ("anxiety").On 16-jul-2021 she experienced burning sensation ("burning sensation all over").On 04-oct-2021 she experienced rectal haemorrhage ("rectal bleeding") and fatigue ("tired").On 25-oct-2021 she experienced erythema ("erythema at the pre auricular level, skin"), skin tightness ("skin tightness") and hives ("hives on the forehead on the right arm elbow").On 30-dec-2021 she experienced seborrhoeic dermatitis ("seborrheic dermatitis"), onychomycosis ("nail mycosis"), keloid scar ("keloid scar") and urticaria ("urticaria").On unknown date she experienced device breakage (seriousness criterion intervention required), haematochezia ("blood stool") and nasal congestion ("nasal congestion").The patient was treated with surgery (on 13-dec-2019 bilateral salpingectomy and on 08-aug-2020 hysterectomy).At the time of the report, the outcomes for abdominal pain, malaise, temperature regulation disorder, abdominal distension, iliac fossa pain, menstrual disorder, headache, pruritus, vaginal bleeding, diarrhoea, vaginal discharge, intermenstrual bleeding, hypogastric pain, pelvic pain, abdominal discomfort, rash, neck pain, groin pain, dermal cyst, constipation, spotting vaginal, insomnia, skin lesion, hypersensitivity, sneezing, seborrhoeic dermatitis, onychomycosis, keloid scar, urticaria, erythema, skin tightness, hives, rectal haemorrhage, fatigue, burning sensation, arthromyalgia, dizziness, disturbance in attention, haematochezia, tooth infection, chest discomfort, cough, vomiting, nausea, pyrexia, laryngitis, dyspnoea, odynophagia, nasal congestion, rhinorrhoea, dermatitis, uterine cervical pain, muscle contracture, genital candidiasis, upper respiratory tract infection, sinusitis, vertigo, pain in hip and the last episode of anxiety were unknown.The reporter considered abdominal discomfort, abdominal distension, abdominal pain, iliac fossa pain, hypogastric pain, the first episode of anxiety, the second episode of anxiety, pain in hip, arthromyalgia, burning sensation, chest discomfort, constipation, cough, dermal cyst, dermatitis, device breakage, diarrhoea, disturbance in attention, dizziness, dyspnoea, erythema, fatigue, genital candidiasis, groin pain, haematochezia, headache, hypersensitivity, insomnia, intermenstrual bleeding, keloid scar, laryngitis, malaise, menstrual disorder, muscle contracture, nasal congestion, nausea, neck pain, odynophagia, onychomycosis, pelvic pain, pruritus, pyrexia, rash, rectal haemorrhage, rhinorrhoea, seborrhoeic dermatitis, sinusitis, skin lesion, skin tightness, sneezing, temperature regulation disorder, tooth infection, upper respiratory tract infection, hives, urticaria, uterine cervical pain, vaginal discharge, vaginal bleeding, spotting vaginal, vertigo and vomiting to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): [abdominal x-ray] on 10-mar-2020: remains of the essure device [defecography] on 02-apr-2019: uterus in rvf with 10 mm endometrium.Normal right ovary.Normal left ovary.No free liquid [full blood count] on 02-apr-2019: 32.2; on 07-aug-2020: leukocytes 12.17 x10 ^9/l lymphocytes 12.1% neutrophils 81.8 % neutrophils 9.96 x10^9/l [pathology test] on 07-aug-2020: essure fragments (20b-26275): - fibrous tissue with minimal inflammatory changes - essure type device is identified 2- uterus (20b-26276): - cervix: squamous metaplasia - endometrium with multiple areas of vascular proliferation, suggestive of endometrial polyps essure device fragment persistence after bilateral salpingectomy.Sample type: uterus.Procedure: hysterectomy.Total samples 2 uteru lot number: a33563 manufacture date: 2012-07 expiration date:2015-07.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All component batches used for manufacturing of this product batch fulfilled the set specifications.Batch documentation did not reveal any deviations during the manufacturing process that could have caused the described complaint reason.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample could not be conducted, as no sample was available.The most recent follow-up information incorporated above includes data received on: 30-jan-2024: quality safety evaluation of ptc.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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 18245842
• MDR Text Key: 329477915
• Report Number: 2951250-2023-03462
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: ESS305
• Device Lot Number: A33563
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN; AMOXICILLIN,CLAVULANIC ACID; AVAMYS; AVAMYS; CEFUROXIME; CEFUROXIME; CETIRIZINA (CETIREX); CETIRIZINA (CETIREX); DESOGESTREL; DESOGESTREL; IBUPROFEN; IBUPROFEN; PARACETAMOL,PSEUDOEPHEDRINE; PARACETAMOL,PSEUDOEPHEDRINE
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female