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

Patient Problems Adhesion(s) (1695); Autoimmune Disorder (1732); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Irritation (1941); Lupus (1956); Menstrual Irregularities (1959); Internal Organ Perforation (1987); Pain (1994); Skin Irritation (2076); Bowel Perforation (2668); 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 device dislocation ("migrated coils / coils ending up in the abdominal wall, the bowels, the kidney, the liver, the ovaries."), pelvic adhesions ("severe pelvic adhesive disorder due to migrated coils"), intestinal perforation ("bowel perforation"), genital haemorrhage ("irregular bleedings"), systemic lupus erythematosus ("autoimmune diseases: lupus"), crohn's disease ("autoimmune diseases: crohns disease"), myasthenia gravis ("autoimmune diseases: myasthenia gravis"), pelvic pain ("debilitating pelvic pain / constant pain") and hypersensitivity ("severe allergic reaction") in na unspecified number of female patients who had essure inserted.The occurrence of additional non-serious events is detailed below.On unknown dates, the patients had essure inserted.On unknown dates, the patients experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), intestinal perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), systemic lupus erythematosus (seriousness criterion medically significant), crohn's disease (seriousness criterion medically significant), myasthenia gravis (seriousness criterion medically significant), pelvic pain (seriousness criterion medically significant), hypersensitivity (seriousness criterion medically significant) with urticaria, rash, skin disorder and scar, irritability ("irritation"), inflammation ("inflammation nos / chronic inflammation"), headache ("headaches"), arthralgia ("joint pain"), arthropathy ("joint deterioration"), fatigue ("extreme fatigue"), abdominal distension ("severe bloating"), blood disorder ("blood disorders") and skin disorder ("skin conditions").The patient was treated with surgery (multiple surgical procedures to repair the injury).At the time of the report, the device dislocation, pelvic adhesions, intestinal perforation, genital haemorrhage, systemic lupus erythematosus, crohn's disease, myasthenia gravis, pelvic pain, hypersensitivity, irritability, inflammation, headache, arthralgia, arthropathy, fatigue, abdominal distension, blood disorder and skin disorder outcome was unknown.The reporter considered abdominal distension, arthralgia, arthropathy, blood disorder, crohn's disease, device dislocation, fatigue, genital haemorrhage, headache, hypersensitivity, inflammation, intestinal perforation, irritability, myasthenia gravis, pelvic adhesions, pelvic pain, skin disorder and systemic lupus erythematosus to be related to essure.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 ("migrated coils / coils ending up in the abdominal wall, the bowels, the kidney, the liver, the ovaries."), pelvic adhesions ("severe pelvic adhesive disorder due to migrated coils"), intestinal perforation ("bowel perforation"), genital haemorrhage ("irregular bleedings"), systemic lupus erythematosus ("autoimmune diseases: lupus"), crohn's disease ("autoimmune diseases: crohns disease"), myasthenia gravis ("autoimmune diseases: myasthenia gravis"), pelvic pain ("debilitating pelvic pain / constant pain") and hypersensitivity ("severe allergic reaction") 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 experienced device dislocation (seriousness criteria medically significant and intervention required), pelvic adhesions (seriousness criterion medically significant), intestinal perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), systemic lupus erythematosus (seriousness criterion medically significant), crohn's disease (seriousness criterion medically significant), myasthenia gravis (seriousness criterion medically significant), pelvic pain (seriousness criterion medically significant), hypersensitivity (seriousness criterion medically significant) with urticaria, rash, skin disorder and scar, irritability ("irritation"), inflammation ("inflammation nos / chronic inflammation"), headache ("headaches"), arthralgia ("joint pain"), arthropathy ("joint deterioration"), fatigue ("extreme fatigue"), abdominal distension ("severe bloating"), blood disorder ("blood disorders") and skin disorder ("skin conditions").The patient was treated with surgery (multiple surgical procedures to repair the injury).At the time of the report, the device dislocation, pelvic adhesions, intestinal perforation, genital haemorrhage, systemic lupus erythematosus, crohn's disease, myasthenia gravis, pelvic pain, hypersensitivity, irritability, inflammation, headache, arthralgia, arthropathy, fatigue, abdominal distension, blood disorder and skin disorder outcome was unknown.The reporter considered abdominal distension, arthralgia, arthropathy, blood disorder, crohn's disease, device dislocation, fatigue, genital haemorrhage, headache, hypersensitivity, inflammation, intestinal perforation, irritability, myasthenia gravis, pelvic adhesions, pelvic pain, skin disorder and systemic lupus erythematosus to be related to essure.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 (product technical complaint).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; mullerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7666684
• MDR Text Key: 113329546
• Report Number: 2951250-2018-02986
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• 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
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention