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); Insufficient Information (3190)

Patient Problems Autoimmune Disorder (1732); Autoimmune Disorder (1732); Erosion (1750); Erosion (1750); Pain (1994); Pain (1994); Increased Sensitivity (2065); Uterine Perforation (2121); Burning Sensation (2146); Burning Sensation (2146); Foreign Body In Patient (2687); No Code Available (3191)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ("3 weeks post operation i haven't done stairs"), skin burning sensation ("left side from mid back to bottom of left thight liked urned skin") and autoimmune disorder ("autoimmune disease") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), skin burning sensation (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), pain of skin ("sensitive skin to touch or temeprature changes"), skin erosion ("skin on left side from mid back to botton of left tight like raw skin") and thermohyperaesthesia ("sensitive skin to touch or temeprature changes").The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the medical device removal, skin burning sensation, autoimmune disorder, pain of skin, skin erosion and thermohyperaesthesia outcome was unknown.The reporter considered autoimmune disorder, medical device removal, pain of skin, skin burning sensation, skin erosion and thermohyperaesthesia to be related to essure.Most recent follow-up information incorporated above includes: on 7-jun-2018: case became incident.New reporter and event medical device removal added.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 ('3 weeks post operation i haven't done stairs / painful'), skin burning sensation ('left side from mid back to bottom of left thight liked urned skin'), autoimmune disorder ('autoimmune disease'), cholecystectomy ('gallbladder removed') and syncope ('i was fainting') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included linaclotide (linzess).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), skin burning sensation (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), syncope (seriousness criterion medically significant), pain of skin ("sensitive skin to touch or temeprature changes"), skin erosion ("skin on left side from mid back to botton of left tight like raw skin"), thermohyperaesthesia ("sensitive skin to touch or temeprature changes"), gastrointestinal bacterial overgrowth ("sibo"), irritable bowel syndrome ("ibsd"), gastrointestinal motility disorder ("bowels were not emptying"), flatulence ("gas pain"), amenorrhoea ("i completely stopped having period"), premature menopause ("early menopause") and abdominal distension ("bloated") and underwent cholecystectomy (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the pelvic pain, skin burning sensation, autoimmune disorder, cholecystectomy, syncope, pain of skin, skin erosion, thermohyperaesthesia, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, flatulence, amenorrhoea, premature menopause and abdominal distension outcome was unknown and the irritable bowel syndrome had not resolved.The reporter considered abdominal distension, amenorrhoea, autoimmune disorder, cholecystectomy, flatulence, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, irritable bowel syndrome, pain of skin, pelvic pain, premature menopause, skin burning sensation, skin erosion, syncope and thermohyperaesthesia to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media: sibo, ibsd, gallbladder removed, bowels were not emptying, pelvic pain, syncope.Most recent follow-up information incorporated above includes: on (b)(6) 2019: follow up 7 &8 processed together.Social media received : events added- gas pain, amenorrhoea, premature menopause, abdominal distension.Reporter added.On (b)(6) 2019: follow up 7 &8 processed together.Social media received : events added- gas pain, amenorrhoea, premature menopause, abdominal distension.Reporter 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('3 weeks post operation i haven't done stairs'), skin burning sensation ('left side from mid back to bottom of left thigh liked turned skin'), autoimmune disorder ('autoimmune disease') and cholecystectomy ('gallbladder removed') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included linaclotide (linzess).On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and cholecystectomy (seriousness criterion medically significant) and experienced skin burning sensation (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), pain of skin ("sensitive skin to touch or temperature changes"), skin erosion ("skin on left side from mid back to bottom of left tight like raw skin"), thermohyperaesthesia ("sensitive skin to touch or temperature changes"), gastrointestinal bacterial overgrowth ("sibo"), irritable bowel syndrome ("ibsd") and gastrointestinal motility disorder ("bowels were not emptying").The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the medical device removal, skin burning sensation, autoimmune disorder, pain of skin, skin erosion, thermohyperaesthesia, gastrointestinal bacterial overgrowth, cholecystectomy and gastrointestinal motility disorder outcome was unknown and the irritable bowel syndrome had not resolved.The reporter considered autoimmune disorder, cholecystectomy, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, irritable bowel syndrome, medical device removal, pain of skin, skin burning sensation, skin erosion and thermohyperaesthesia to be related to essure.Concerning the injuries reported in this case, the following one/ones were reported via social media: "sibo, ibsd, gallbladder removed, bowels were not emptying." most recent follow-up information incorporated above includes: on 17-jul-2019: social media received.Events sibo, ibsd, gallbladder removed and bowels were not emptying 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('3 weeks post operation i haven't done stairs / painful'), skin burning sensation ('left side from mid back to bottom of left thight liked urned skin'), autoimmune disorder ('autoimmune disease'), cholecystectomy ('gallbladder removed') and syncope ('i was fainting') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included linaclotide (linzess).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), skin burning sensation (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), syncope (seriousness criterion medically significant), pain of skin ("sensitive skin to touch or temeprature changes"), skin erosion ("skin on left side from mid back to botton of left tight like raw skin"), thermohyperaesthesia ("sensitive skin to touch or temeprature changes"), gastrointestinal bacterial overgrowth ("sibo"), irritable bowel syndrome ("ibsd") and gastrointestinal motility disorder ("bowels were not emptying") and underwent cholecystectomy (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the pelvic pain, skin burning sensation, autoimmune disorder, cholecystectomy, syncope, pain of skin, skin erosion, thermohyperaesthesia, gastrointestinal bacterial overgrowth and gastrointestinal motility disorder outcome was unknown and the irritable bowel syndrome had not resolved.The reporter considered autoimmune disorder, cholecystectomy, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, irritable bowel syndrome, pain of skin, pelvic pain, skin burning sensation, skin erosion, syncope and thermohyperaesthesia to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media: sibo, ibsd, gallbladder removed, bowels were not emptying, pelvic pain, syncope.Most recent follow-up information incorporated above includes: on (b)(6)2019: pfs received- new event fainting added.Event coding changed from medical device removal to pelvic pain female.Reporters information were added.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 embedded device ('many rouge missing coil are later discovered inside uterus embedded in scar adhesions not viewable with imaging'), device expulsion ('many rouge missing coil are later discovered inside uterus embedded in scar adhesions not viewable with imaging') and pelvic pain ('3 weeks post operation i haven't done stairs / painful') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Concomitant products included linaclotide (linzess).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criterion medically significant), skin burning sensation ("left side from mid back to bottom of left thight liked urned skin"), autoimmune disorder ("autoimmune disease"), syncope ("i was fainting"), pain of skin ("sensitive skin to touch or temperature changes"), skin erosion ("skin on left side from mid back to bottom of left tight like raw skin"), thermohyperaesthesia ("sensitive skin to touch or temperature changes"), gastrointestinal bacterial overgrowth ("sibo"), irritable bowel syndrome ("ibsd"), gastrointestinal motility disorder ("bowels were not emptying"), flatulence ("gas pain"), amenorrhoea ("i completely stopped having period"), premature menopause ("early menopause"), abdominal distension ("bloated"), hot flush ("hot flashes") and night sweats ("night sweats") and underwent cholecystectomy ("gallbladder removed").The patient was treated with surgery (hysterectomy).Essure was removed.At the time of the report, the embedded device, device expulsion, pelvic pain, skin burning sensation, autoimmune disorder, cholecystectomy, syncope, pain of skin, skin erosion, thermohyperaesthesia, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, flatulence, amenorrhoea, premature menopause and abdominal distension outcome was unknown, the irritable bowel syndrome had not resolved and the hot flush and night sweats had resolved.The reporter considered abdominal distension, amenorrhoea, autoimmune disorder, cholecystectomy, device expulsion, embedded device, flatulence, gastrointestinal bacterial overgrowth, gastrointestinal motility disorder, hot flush, irritable bowel syndrome, night sweats, pain of skin, pelvic pain, premature menopause, skin burning sensation, skin erosion, syncope and thermohyperaesthesia to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media: essure embedment, device expulsion, sibo, ibsd, gallbladder removed, bowels were not emptying, pelvic pain, syncope, hot flash and night sweat.Most recent follow-up information incorporated above includes: on 14-jan-2020: social media received.New events hot flashes and night sweats were added.Reporter information was added.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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: 7654177
• MDR Text Key: 112840827
• Report Number: 2951250-2018-02938
• 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,Followup,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other; Required Intervention