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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994); Cramp(s) (2193); Intermenstrual Bleeding (2665)

Event Date 01/01/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pains / pain") and genital haemorrhage ("excessive bleeding") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2012, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and genital haemorrhage (seriousness criterion medically significant).On an unknown date, the patient experienced abdominal pain lower ("cramping").The patient was treated with surgery (underwent hysterectomy).At the time of the report, the pelvic pain, genital haemorrhage and abdominal pain lower outcome was unknown.The reporter considered abdominal pain lower, genital haemorrhage and pelvic pain to be related to essure.The reporter commented: she began treating conservatively for these injuries in 2013.She continues to suffer from and treat injuries related to the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: her fallopian tubes were occluded.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 ("pelvic pains / pain") and genital haemorrhage ("excessive bleeding/ abnormal bleeding (general)") in a 39-year-old female patient who had essure (batch no.898929) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included asthma and multiple allergies.Concomitant products included fluticasone propionate;salmeterol xinafoate (advair) since 2007 and montelukast sodium (singulair) since 2007.On (b)(6) 2012, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2014, the patient experienced dental caries ("dental problems 4 cavities").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and nausea ("nausea").On (b)(6) 2017, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and amenorrhoea ("missed periods"), 4 years 9 months after insertion of essure.On an unknown date, the patient experienced abdominal pain lower ("cramping"), dry skin ("rashes or skin conditions type: dry patches of skin on arms and occasionally on back"), migraine ("migraines"), headache ("headaches") and back pain ("back side pain").The patient was treated with surgery (underwent hysterectomy).At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain lower, urinary tract infection, dysmenorrhoea, dental caries, dry skin, vaginal haemorrhage, menorrhagia, amenorrhoea, migraine, headache, nausea and back pain outcome was unknown.The reporter considered abdominal pain lower, amenorrhoea, back pain, dental caries, dry skin, dysmenorrhoea, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: she began treating conservatively for these injuries in 2013.She continues to suffer from and treat injuries related to the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: results: her fallopian tubes were occluded.Most recent follow-up information incorporated above includes: on (b)(6) 2018: reporters added and patient demographic added.Updated suspect drug indication and lot number.Added events abnormal bleeding (general), infection (bladder/ urinary tract/vaginal) type: uti, rashes or skin conditions type: dry patches of skin on arms and occasionally on back, dental problems 4 cavities, dysmenorrhea (cramping), abnormal bleeding (vaginal, menorrhagia), missed periods, migraines, headaches, nausea, back side pain.Updated onset and reported event term.Incident: we received a lot number/returned sample 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pelvic pains / pain") and genital haemorrhage ("excessive bleeding/ abnormal bleeding (general)") in a 39-year-old female patient who had essure (batch no.898929) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included asthma and multiple allergies.Concomitant products included fluticasone propionate;salmeterol xinafoate (advair) since 2007 and montelukast sodium (singulair) since 2007.On (b)(6) 2012, the patient had essure inserted.In 2013, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required) and genital haemorrhage (seriousness criterion medically significant).In (b)(6) 2013, the patient experienced urinary tract infection ("infection (bladder/ urinary tract/vaginal) type: uti").In (b)(6) 2014, the patient experienced dental caries ("dental problems 4 cavities").In (b)(6) 2015, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and nausea ("nausea").On (b)(6) 2017, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)") and amenorrhoea ("missed periods"), 4 years 9 months after insertion of essure.On an unknown date, the patient experienced abdominal pain lower ("cramping"), dry skin ("rashes or skin conditions type: dry patches of skin on arms and occasionally on back"), migraine ("migraines"), headache ("headaches") and back pain ("back side pain").The patient was treated with surgery (underwent hysterectomy).At the time of the report, the pelvic pain, genital haemorrhage, abdominal pain lower, urinary tract infection, dysmenorrhoea, dental caries, dry skin, vaginal haemorrhage, menorrhagia, amenorrhoea, migraine, headache, nausea and back pain outcome was unknown.The reporter considered abdominal pain lower, amenorrhoea, back pain, dental caries, dry skin, dysmenorrhoea, genital haemorrhage, headache, menorrhagia, migraine, nausea, pelvic pain, urinary tract infection and vaginal haemorrhage to be related to essure.The reporter commented: she began treating conservatively for these injuries in 2013.She continues to suffer from and treat injuries related to the essure device.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in 2012: results: her fallopian tubes were occluded.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 7-jan-2019: quality safety evaluation of product technical complaints.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.

• 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: 6964574
• MDR Text Key: 89814215
• Report Number: 2951250-2017-05243
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

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 Expiration Date: 08/01/2014
• Device Model Number: ESS305
• Device Lot Number: 898929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 12/05/2018; 01/07/2019
• Supplement Dates FDA Received: 12/18/2018; 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVAIR; ADVAIR; SINGULAIR; SINGULAIR
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR