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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Myalgia (2238); Arthralgia (2355); Heavier Menses (2666)

Event Date 05/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), abdominal pain lower ("severe lower abdominal pain"), genital haemorrhage ("abnormal bleeding general") and abdominal adhesions ("adhesions") in a (b)(6) female patient who had essure (batch no.B59461) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included migraine, headache, cesarean section, uterine dilation and curettage (for termination of pregnancy), vaginal discharge, myalgia, joint pain and obesity.Previously administered products included for an unreported indication: dyclonine hydrochlo and doxycycline hyclate.Past adverse reactions to the above products included drug hypersensitivity with dyclonine hydrochlo; and pyrexia with doxycycline hyclate.On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criterion medically significant) and dysmenorrhoea ("severe menstrual pain/dysmenorrhea (cramping)").In (b)(6) 2014, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse),").In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), back pain ("back pain"), migraine ("migraines/migraines / headaches"), headache ("migraines / headaches"), fatigue ("fatigue") and abdominal pain ("pain").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), abdominal adhesions (seriousness criterion medically significant), menorrhagia ("prolonged menses/abnormal/heavy menstrual bleeding/abnormal bleeding (vaginal, menorrhagia") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia").The patient was treated with thomapyrin n (excedrin migraine), ibuprofen (advil), surgery (bilateral salpingectomy and intra-abdominal lysis of adhesions).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, dysmenorrhoea, back pain, vaginal haemorrhage, dyspareunia, fatigue and abdominal pain had resolved and the abdominal pain lower, abdominal adhesions, migraine and headache outcome was unknown.The reporter considered abdominal adhesions, abdominal pain, abdominal pain lower, back pain, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff¿s symptoms have mostly resolved, following surgery.She did not had complications or problems that occurred at the time of your essure placement procedure.Diagnostic results (normal ranges are provided in parenthesis if available): (b)(6) test - on an unknown date: (b)(6).Hysterosalpingogram - in september 2014: full occlusion of fallopian tubes confirmed.Smear cervix - on (b)(6) 2012: negative.Last menstrual period was (b)(6) 2015.On (b)(6) 2015, transvaginal ultrasound: impression: heterogeneous myometrium.Nabothian cyst(s).Bilateral essure seen.Most recent follow-up information incorporated above includes: on 28-feb-2018: plaintiff fact sheet and medical records received: reporters details added.Lot number added.Event added as abnormal bleeding (vaginal, menorrhagia), migraines / headaches, dyspareunia (painful sexual intercourse), abdominal ,pelvic pain, fatigue, abnormal bleeding general.Concomitant, historical drugs and treatment drugs, lab data were added.Incident.At the time of reporting, 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"), abdominal pain lower ("severe lower abdominal pain"), genital haemorrhage ("abnormal bleeding general") and abdominal adhesions ("adhesions") in a 36-year-old female patient who had essure (batch no.B59461) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included migraine, headache, cesarean section, uterine dilation and curettage (for termination of pregnancy), vaginal discharge, myalgia, joint pain and obesity.Previously administered products included for an unreported indication: dyclonine hydrochlo and doxycycline hyclate.Past adverse reactions to the above products included drug hypersensitivity with dyclonine hydrochlo; and pyrexia with doxycycline hyclate.On (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced genital haemorrhage (seriousness criterion medically significant) and dysmenorrhoea ("severe menstrual pain/dysmenorrhea (cramping)").In (b)(6) 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), migraine ("migraines/migraines / headaches"), headache ("migraines / headaches"), dyspareunia ("dyspareunia (painful sexual intercourse),") and fatigue ("fatigue").In 2014, the patient experienced back pain ("back pain") and abdominal pain ("pain").On an unknown date, the patient experienced abdominal pain lower (seriousness criteria medically significant and intervention required), abdominal adhesions (seriousness criterion medically significant), menorrhagia ("prolonged menses/abnormal/heavy menstrual bleeding/abnormal bleeding (vaginal, menorrhagia") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia").The patient was treated with thomapyrin n (excedrin migraine), ibuprofen (advil), surgery (bilateral salpingectomy and intra-abdominal lysis of adhesions), surgery (bilateral salpingectomy and intra-abdominal lysis of adhesions) and surgery (intra-abdominal lysis of adhesions).Essure was removed on (b)(6) 2016.At the time of the report, the pelvic pain, genital haemorrhage, menorrhagia, dysmenorrhoea, back pain, vaginal haemorrhage, dyspareunia, fatigue and abdominal pain had resolved and the abdominal pain lower, abdominal adhesions, migraine and headache outcome was unknown.The reporter considered abdominal adhesions, abdominal pain, abdominal pain lower, back pain, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, menorrhagia, migraine, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: plaintiff¿s symptoms have mostly resolved, following surgery.She did not had complications or problems that occurred at the time of your essure placement procedure.Diagnostic results (normal ranges are provided in parenthesis if available): human papilloma virus test - on an unknown date: negative.Hysterosalpingogram - in (b)(6) 2014: full occlusion of fallopian tubes confirmed.Smear cervix - on (b)(6) 2012: negative.Last menstrual period was (b)(6) 2015.(b)(6) 2015, transvaginal ultrasound: impression: heterogeneous myometrium.Nabothian cyst(s).Bilateral essure seen.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-jul-2018: quality safety evaluation of ptc.Incident: at the time of reporting, 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: 7474949
• MDR Text Key: 106960895
• Report Number: 2951250-2018-01989
• 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: 07/20/2018

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 Expiration Date: 07/01/2016
• Device Model Number: ESS305
• Device Lot Number: B59461
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 07/13/2018
• Supplement Dates FDA Received: 07/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 36 YR