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

Model Number ESS305

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain") in a female patient who had essure inserted.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).The patient was treated with surgery (to remove the essure implant).Essure was removed.At the time of the report, the pelvic pain outcome was unknown.The reporter considered pelvic pain to be related to essure.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gallstones, anemia, abdominal pain and uterine bleeding.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia ("menorrhagia (heavy menstrual bleeding)"), abdominal pain ("abdominal pain"), back pain ("back pain"), iron deficiency anaemia ("anemia"), blood disorder ("blood/heart disorder"), cardiac disorder ("blood/heart disorder"), migraine ("migraine"), headache ("headache"), nausea ("nausea") and nervous system disorder ("neurological condition/problem").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menorrhagia, abdominal pain, back pain, iron deficiency anaemia, blood disorder, cardiac disorder, migraine, headache, nausea and nervous system disorder outcome was unknown.The reporter considered abdominal pain, back pain, blood disorder, cardiac disorder, headache, iron deficiency anaemia, menorrhagia, migraine, nausea, nervous system disorder and pelvic pain to be related to essure.The reporter commented: received treatment for: abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), anemia from chronic blood loss, pelvic pain, blood/heart disorder, migraine, headache, nausea, neurological condition/problem.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2012: result not available.Most recent follow-up information incorporated above includes: on 22-nov-2019: pfs received: new events: abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), anemia from chronic blood loss, blood/heart disorder, migraine, headache, nausea, neurological condition/problem were added.Lab data added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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 reported by a lawyer and describes the occurrence of pelvic pain ('pain') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gallstones, anemia, abdominal pain, uterine bleeding and hypothyroidism.Concomitant products included ibuprofen (motrin children) from 2012 to 2016 and ondansetron (zofran melt) from 2012 to 2016.On (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced menorrhagia ("menorrhagia (heavy menstrual bleeding) / abnormal bleeding (menorrhagia)"), back pain ("back pain"), iron deficiency anaemia ("anemia / blood or heart disorder/condition type: anemia"), migraine ("migraines / headaches"), headache ("headache"), nausea ("nausea"), vaginal haemorrhage ("abnormal bleeding (vaginal)"), dizziness ("neurological conditions or problems type: dizziness"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain lower ("lower abdominal pain") and underwent transfusion ("several blood transfusions").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain ("abdominal pain"), blood disorder ("blood/heart disorder"), cardiac disorder ("blood/heart disorder") and nervous system disorder ("neurological condition/problem").The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, menorrhagia, abdominal pain, iron deficiency anaemia, blood disorder, cardiac disorder, headache, nausea, nervous system disorder, transfusion and vaginal haemorrhage outcome was unknown, the back pain, dysmenorrhoea and abdominal pain lower was resolving and the migraine and dizziness had resolved.The reporter considered abdominal pain, abdominal pain lower, back pain, blood disorder, cardiac disorder, dizziness, dysmenorrhoea, headache, iron deficiency anaemia, menorrhagia, migraine, nausea, nervous system disorder, pelvic pain, transfusion and vaginal haemorrhage to be related to essure.The reporter commented: received treatment for: abdominal pain, back pain, menorrhagia (heavy menstrual bleeding), anemia from chronic blood loss, pelvic pain, blood/heart disorder, migraine, headache, nausea, neurological condition/problem.Diagnostic results (normal ranges are provided in parenthesis if available): imaging procedure - on (b)(6) 2012: result not available.Ultrasound scan vagina - in (b)(6) 2012: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 19-may-2020: plaintiff fact sheet received.Events added from pfs- abnormal bleeding (vaginal), several blood transfusions, neurological conditions or problems type: dizziness, dysmenorrhea (cramping), lower abdominal pain.Outcome of event back pain, migraine were updated.Medical history, reporter information, concomitant drug, lab data were added.No lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances 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
• MDR Report Key: 7147484
• MDR Text Key: 95809867
• Report Number: 2951250-2017-11142
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTRIN CHILDREN; ZOFRAN MELT
• Patient Outcome(s): Other; Required Intervention