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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Autoimmune Reaction (1733); Flatus (1865); Headache (1880); Hemorrhage/Bleeding (1888); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Rash (2033); Dizziness (2194); Weight Changes (2607); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("the left one has migrated south"), genital haemorrhage ("i would bleed huge- i mean size of your first bloodclots that would last 5-7 days.") and autoimmune disorder ("autoimmune issue") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), abdominal distension ("bloating"), nausea ("nausea"), headache ("crazy headaches"), dizziness ("dizziness feeling like i was going to faint"), rash papular ("bumps that looked like a weired rash on my legs"), pruritus ("itchiness (like i wanted to claw my skin off )"), menstruation irregular ("irregular period"), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), amnesia ("memory loss"), weight increased ("weight gain") and autoimmune disorder (seriousness criterion medically significant).The patient was treated with surgery (underwent hysterectomy).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, abdominal distension, nausea, headache, dizziness, rash papular, pruritus, menstruation irregular, genital haemorrhage, pelvic pain, amnesia, weight increased and autoimmune disorder had resolved.The reporter considered abdominal distension, amnesia, autoimmune disorder, device dislocation, dizziness, genital haemorrhage, headache, menstruation irregular, nausea, pelvic pain, pruritus, rash papular and weight increased to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: device dislocation, abdominal distension, nausea, headache, dizziness, rash popular, pruritus, irregular period, pelvic pain, amnesia, weight increased, autoimmune disorder" 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

Ntaneous case was reported by a lawyer and describes the occurrence of device dislocation ("the left one has migrated south"), genital haemorrhage ("i would bleed huge- i mean size of your first bloodclots that would last 5-7 days.") and autoimmune disorder ("autoimmune issue") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), abdominal distension ("bloating"), nausea ("nausea"), headache ("crazy headaches"), dizziness ("dizziness feeling like i was going to faint"), rash papular ("bumps that looked like a weired rash on my legs"), pruritus ("itchiness (like i wanted to claw my skin off )"), menstruation irregular ("irregular period"), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), amnesia ("memory loss"), weight increased ("weight gain") and autoimmune disorder (seriousness criterion medically significant).The patient was treated with surgery (underwent hysterectomy).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, abdominal distension, nausea, headache, dizziness, rash papular, pruritus, menstruation irregular, genital haemorrhage, pelvic pain, amnesia, weight increased and autoimmune disorder had resolved.The reporter considered abdominal distension, amnesia, autoimmune disorder, device dislocation, dizziness, genital haemorrhage, headache, menstruation irregular, nausea, pelvic pain, pruritus, rash papular and weight increased to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: device dislocation, abdominal distension, nausea, headache, dizziness, rash popular, pruritus, irregular period, pelvic pain, amnesia, weight increased, autoimmune disorder" quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 31-oct-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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ('the left one has migrated south'), autoimmune disorder ('autoimmune issue') and genital haemorrhage ('i would bleed huge- i mean size of your first bloodclots that would last 5-7 days.') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), autoimmune disorder (seriousness criterion medically significant), abdominal distension ("bloating"), nausea ("nausea"), headache ("crazy headaches"), dizziness ("dizziness feeling like i was going to faint"), rash papular ("bumps that looked like a weired rash on my legs"), pruritus ("itchiness (like i wanted to claw my skin off )"), menstruation irregular ("irregular period"), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("pain"), amnesia ("memory loss"), abdominal pain ("my belly that's a real pain") and flatulence ("i still have gas") and was found to have weight increased ("weight gain").The patient was treated with surgery (underwent hysterectomy, coils along with tubes, cervix).Essure was removed in (b)(6) 2015.At the time of the report, the device dislocation, autoimmune disorder, abdominal distension, nausea, headache, dizziness, rash papular, pruritus, menstruation irregular, genital haemorrhage, pelvic pain, amnesia and weight increased had resolved and the abdominal pain and flatulence outcome was unknown.The reporter considered abdominal distension, abdominal pain, amnesia, autoimmune disorder, device dislocation, dizziness, flatulence, genital haemorrhage, headache, menstruation irregular, nausea, pelvic pain, pruritus, rash papular and weight increased to be related to essure.¿concerning the injuries reported in this case, the following one/ones were described in social media: device dislocation, abdominal distension, nausea, headache, dizziness, rash popular, pruritus, irregular period, pelvic pain, amnesia, weight increased, autoimmune disorder, flatulence , abdominal pain.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 3-dec-2019: social media received- new events i still have gas , my belly that's a real pain were added.New reporter were added.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.

• 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: 7633210
• MDR Text Key: 112150782
• Report Number: 2951250-2018-02773
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention