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

Model Number ESS305

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Headache (1880); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Weight Changes (2607); Genital Bleeding (4507)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and genital haemorrhage ('general abnormal bleeding') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not performed essure confirmation test".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), female sexual dysfunction ("apareunia"), back pain ("back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), rash ("rash/skin condition"), vaginal discharge ("vaginal discharge"), cystitis ("bladder infection"), nausea ("nausea") and migraine ("migraine") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, back pain, abdominal pain and dysmenorrhoea had resolved and the rash, vaginal discharge, cystitis, weight increased, nausea and migraine outcome was unknown.The reporter considered abdominal pain, back pain, cystitis, dysmenorrhoea, female sexual dysfunction, genital haemorrhage, migraine, nausea, pelvic pain, rash, vaginal discharge and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-sep-2019: reporters details updated and patient demographics and laboratory data were added.Essure indication updated.On (b)(6) 2010, she implanted essure (previously reported as 2010).On (b)(6) 2018, she explanted essure.Injury events was updated to apareunia, back pain, pelvic pain,/ abdominal pain, dysmenorrhea (cramping), general abnormal bleeding, rash/skin condition, vaginal discharge, bladder infection, weight gain, nausea, migraine, plaintiff did not undergo essure confirmation test.No lot number 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 ('pelvic pain') and genital haemorrhage ('general abnormal bleeding') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not performed essure confirmation test".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), female sexual dysfunction ("apareunia"), back pain ("back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), rash ("rash/skin condition"), vaginal discharge ("vaginal discharge"), cystitis ("bladder infection"), nausea ("nausea"), migraine ("migraine / migraines / headaches"), vaginal haemorrhage ("vaginal bleeding"), menorrhagia ("menorrhagia"), bladder disorder ("bladder disorder"), urinary tract infection ("uti"), abscess ("abscess"), furuncle ("boils") and complication of device removal ("basic complications from surgery") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, back pain, abdominal pain and dysmenorrhoea had resolved and the rash, vaginal discharge, cystitis, weight increased, nausea, migraine, vaginal haemorrhage, menorrhagia, bladder disorder, urinary tract infection, abscess, furuncle and complication of device removal outcome was unknown.The reporter considered abdominal pain, abscess, back pain, bladder disorder, complication of device removal, cystitis, dysmenorrhoea, female sexual dysfunction, furuncle, genital haemorrhage, menorrhagia, migraine, nausea, pelvic pain, rash, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.1 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: pfs received.Events vaginal bleeding, menorrhagia, bladder disorder, uti, abscess and boils added.Fu4 and fu5 process together.On (b)(6) 2019: fu4 and fu5 process together.Incident: 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 ('pelvic pain') and genital haemorrhage ('general abnormal bleeding') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not performed essure confirmation test".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), female sexual dysfunction ("apareunia"), back pain ("back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), rash ("rash/skin condition"), vaginal discharge ("vaginal discharge"), cystitis ("bladder infection"), nausea ("nausea") and migraine ("migraine") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, back pain, abdominal pain and dysmenorrhoea had resolved and the rash, vaginal discharge, cystitis, weight increased, nausea and migraine outcome was unknown.The reporter considered abdominal pain, back pain, cystitis, dysmenorrhoea, female sexual dysfunction, genital haemorrhage, migraine, nausea, pelvic pain, rash, vaginal discharge and weight increased to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: patient problem code added.No new follow-up information was received from the reporter.No lot number 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 ('pelvic pain') and genital haemorrhage ('general abnormal bleeding') in an adult female patient who had essure (batch no.700648 - inv) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not performed essure confirmation test".The patient's medical history included chronic cervicitis and abnormal uterine bleeding.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), female sexual dysfunction ("apareunia"), back pain ("back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), rash ("rash/skin condition"), vaginal discharge ("vaginal discharge"), cystitis ("bladder infection"), nausea ("nausea"), migraine ("migraine / migraines / headaches"), vaginal haemorrhage ("vaginal bleeding"), heavy menstrual bleeding ("menorrhagia"), bladder disorder ("bladder disorder"), urinary tract infection ("uti"), abscess ("abscess"), furuncle ("boils") and complication of device removal ("basic complications from surgery") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, back pain, abdominal pain and dysmenorrhoea had resolved and the rash, vaginal discharge, cystitis, weight increased, nausea, migraine, vaginal haemorrhage, heavy menstrual bleeding, bladder disorder, urinary tract infection, abscess, furuncle and complication of device removal outcome was unknown.The reporter considered abdominal pain, abscess, back pain, bladder disorder, complication of device removal, cystitis, dysmenorrhoea, female sexual dysfunction, furuncle, genital haemorrhage, heavy menstrual bleeding, migraine, nausea, pelvic pain, rash, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2010.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.1 kg/sqm.Lot number: 700648.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Quality-safety evaluation of ptc: no defect could be confirmed by the manufacturer.  all product batches have met the specifications regarding labeling, material, and process controls at time of release.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 and batch record review could not be conducted, as no sample or batch number were available.Most recent follow-up information incorporated above includes: on 3-jun-2021: quality-safety evaluation of ptc.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') and genital haemorrhage ('general abnormal bleeding') in an adult female patient who had essure (batch no.700648) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not performed essure confirmation test".The patient's medical history included chronic cervicitis and abnormal uterine bleeding.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), female sexual dysfunction ("apareunia"), back pain ("back pain"), abdominal pain ("abdominal pain"), dysmenorrhoea ("dysmenorrhea (cramping)"), rash ("rash/skin condition"), vaginal discharge ("vaginal discharge"), cystitis ("bladder infection"), nausea ("nausea"), migraine ("migraine / migraines / headaches"), vaginal haemorrhage ("vaginal bleeding"), heavy menstrual bleeding ("menorrhagia"), bladder disorder ("bladder disorder"), urinary tract infection ("uti"), abscess ("abscess"), furuncle ("boils") and complication of device removal ("basic complications from surgery") and was found to have weight increased ("weight gain").The patient was treated with surgery (hysterectomy (full)).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, genital haemorrhage, female sexual dysfunction, back pain, abdominal pain and dysmenorrhoea had resolved and the rash, vaginal discharge, cystitis, weight increased, nausea, migraine, vaginal haemorrhage, heavy menstrual bleeding, bladder disorder, urinary tract infection, abscess, furuncle and complication of device removal outcome was unknown.The reporter considered abdominal pain, abscess, back pain, bladder disorder, complication of device removal, cystitis, dysmenorrhoea, female sexual dysfunction, furuncle, genital haemorrhage, heavy menstrual bleeding, migraine, nausea, pelvic pain, rash, urinary tract infection, vaginal discharge, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2010.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.1 kg/sqm.Lot number: 700648.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain.Most recent follow-up information incorporated above includes: on 3-may-2021: mr received.Reporter information, patient medical history, product lot number, rcc 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 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
• MDR Report Key: 9160729
• MDR Text Key: 168591438
• Report Number: 2951250-2019-09565
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 700648 - INV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 09/30/2019; 05/03/2021; 06/03/2021
• Supplement Dates FDA Received: 10/08/2019; 10/11/2019; 05/13/2021; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 54