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); Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Anemia (1706); Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Cyst(s) (1800); Diarrhea (1811); Flatus (1865); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Lupus (1956); Menstrual Irregularities (1959); Nausea (1970); Neurological Deficit/Dysfunction (1982); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Blurred Vision (2137); Burning Sensation (2146); Tingling (2171); Anxiety (2328); Injury (2348); Arthralgia (2355); Depression (2361); Numbness (2415); Abdominal Cramps (2543); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("chronic pain"), systemic lupus erythematosus ("tested positive for lupus") and rheumatoid arthritis ("rheumatoid arthritis") in a (b)(6) 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 2014, the patient experienced vision blurred ("blurred vision").In (b)(6) 2014, the patient experienced post-traumatic stress disorder ("ptsd").In 2015, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant) and tooth disorder ("dental problem").In (b)(6) 2016, the patient experienced nerve injury ("nerve damage").In (b)(6) 2017, the patient experienced diarrhoea ("chronic diarrhoea").In (b)(6) 2017, the patient experienced gastrooesophageal reflux disease ("gerd").In (b)(6) 2017, the patient experienced anaemia ("anemia").In (b)(6) 2017, the patient experienced disturbance in attention ("difficulty focus").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("lower abdominal pain, cramping"), headache ("headaches"), migraine ("migraines"), hypoaesthesia ("numbness in the hands and feet"), paraesthesia ("tingling in hands and feet"), dysmenorrhoea ("severe menstrual cramping"), menorrhagia ("persistent increased menstrual flow"), cyst ("cysts"), alopecia ("hair loss"), dyspareunia ("pain during intercourse"), fatigue ("fatigue"), autoimmune disorder ("autoimmune disease"), neuralgia ("nerve pain"), arthralgia ("joint pain"), vaginal haemorrhage ("abnormal vaginal bleeding"), urinary tract infection ("uti"), nausea ("nausea"), allergy to metals ("nickel allergy"), anxiety ("anxiety"), depression ("depression"), photosensitivity reaction ("sun sensitivity"), burning sensation ("burning"), vaginal discharge ("vaginal discharge"), abdominal pain ("abdominal pain"), bone pain ("bone pain") and panic attack ("panic attack").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy and left oophorectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dyspareunia, autoimmune disorder, diarrhoea and anxiety had resolved, the abdominal pain lower, headache, migraine, hypoaesthesia, paraesthesia, dysmenorrhoea, menorrhagia, cyst, alopecia, fatigue, neuralgia, arthralgia, vaginal haemorrhage, systemic lupus erythematosus, rheumatoid arthritis, tooth disorder, urinary tract infection, nausea, nerve injury, allergy to metals, depression, photosensitivity reaction, burning sensation, vaginal discharge, vision blurred, abdominal pain, post-traumatic stress disorder, disturbance in attention, gastrooesophageal reflux disease, anaemia and bone pain outcome was unknown and the panic attack had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anaemia, anxiety, arthralgia, autoimmune disorder, bone pain, burning sensation, cyst, depression, diarrhoea, disturbance in attention, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, headache, hypoaesthesia, menorrhagia, migraine, nausea, nerve injury, neuralgia, panic attack, paraesthesia, pelvic pain, photosensitivity reaction, post-traumatic stress disorder, rheumatoid arthritis, systemic lupus erythematosus, tooth disorder, urinary tract infection, vaginal discharge, vaginal haemorrhage and vision blurred to be related to essure.Most recent follow-up information incorporated above includes: on 12-mar-2018: pfs and medical record received:the event abnormal vaginal bleeding, tested positive for lupus, rheumatoid arthritis, dental problem, chronic diarrhea, uti, nausea, nerve damage, nickel allergy, anxiety, depression, sun sensitivity, burning, vaginal discharge, blurred vision, abdominal pain, post traumatic stress disorder, difficulty focus, gerd, anemia, bone pain, panic attack added.Reporters,concomitant medication added.She underwent a total hysterectomy, bilateral salpingectomy and left oophorectomy.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 ("chronic pain"), systemic lupus erythematosus ("tested positive for lupus") and rheumatoid arthritis ("rheumatoid arthritis") in a 34-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's previously administered products included for an unreported indication: depo provera.Concurrent conditions included tooth decay, tooth fracture, tooth infection, tooth extraction, vomiting and dehydration.On (b)(6) 2012, the patient had essure inserted.In 2014, the patient experienced vision blurred ("blurred vision").In (b)(6) 2014, the patient experienced post-traumatic stress disorder ("ptsd").In 2015, the patient experienced systemic lupus erythematosus (seriousness criterion medically significant), rheumatoid arthritis (seriousness criterion medically significant) and tooth disorder ("dental problem").In (b)(6) 2016, the patient experienced nerve injury ("nerve damage").In (b)(6) 2017, the patient experienced diarrhea ("chronic diarrhea").In (b)(6) 2017, the patient experienced gastrooesophageal reflux disease ("gerd").In (b)(6) 2017, the patient experienced anemia ("anemia").In (b)(6) 2017, the patient experienced disturbance in attention ("difficulty focus").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain lower ("lower abdominal pain, cramping"), headache ("headaches"), migraine ("migraines"), hypoaesthesia ("numbness in the hands and feet"), paraesthesia ("tingling in hands and feet"), dysmenorrhoea ("severe menstrual cramping"), menorrhagia ("persistent increased menstrual flow"), cyst ("cysts"), alopecia ("hair loss"), dyspareunia ("pain during intercourse"), fatigue ("fatigue"), autoimmune disorder ("autoimmune disease"), neuralgia ("nerve pain"), arthralgia ("joint pain"), vaginal haemorrhage ("abnormal vaginal bleeding"), urinary tract infection ("uti"), nausea ("nausea"), allergy to metals ("nickel allergy"), anxiety ("anxiety"), depression ("depression"), photosensitivity reaction ("sun sensitivity"), burning sensation ("burning"), vaginal discharge ("vaginal discharge"), abdominal pain ("abdominal pain"), bone pain ("bone pain") and panic attack ("panic attack").The patient was treated with surgery (total hysterectomy, bilateral salpingectomy and left oophorectomy).Essure was removed on (b)(6) 2017.At the time of the report, the pelvic pain, dyspareunia, autoimmune disorder, diarrhoea and anxiety had resolved, the abdominal pain lower, headache, migraine, hypoaesthesia, paraesthesia, dysmenorrhoea, menorrhagia, cyst, alopecia, fatigue, neuralgia, arthralgia, vaginal hemorrhage, systemic lupus erythematosus, rheumatoid arthritis, tooth disorder, urinary tract infection, nausea, nerve injury, allergy to metals, depression, photosensitivity reaction, burning sensation, vaginal discharge, vision blurred, abdominal pain, post-traumatic stress disorder, disturbance in attention, gastrooesophageal reflux disease, anaemia and bone pain outcome was unknown and the panic attack had not resolved.The reporter considered abdominal pain, abdominal pain lower, allergy to metals, alopecia, anaemia, anxiety, arthralgia, autoimmune disorder, bone pain, burning sensation, cyst, depression, diarrhoea, disturbance in attention, dysmenorrhoea, dyspareunia, fatigue, gastrooesophageal reflux disease, headache, hypoaesthesia, menorrhagia, migraine, nausea, nerve injury, neuralgia, panic attack, paraesthesia, pelvic pain, photosensitivity reaction, post-traumatic stress disorder, rheumatoid arthritis, systemic lupus erythematosus, tooth disorder, urinary tract infection, vaginal discharge, vaginal hemorrhage and vision blurred to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 6-aug-2018: quality safety evaluation of ptc.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.

• 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: 7520663
• MDR Text Key: 108490885
• Report Number: 2951250-2018-02192
• 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
• Report Date: 08/10/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR