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

Model Number ESS305

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Autoimmune Disorder (1732); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Menstrual Irregularities (1959); Pain (1994); Perforation (2001); Toxicity (2333)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("migration/perforation"), genital haemorrhage ("bleeding") and autoimmune disorder ("autoimmune-like symptoms") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gestational diabetes, uti, anemia, epigastric pain, nausea, vomiting, bloody stool, dysuria, pains in legs, lethargy, painful feet, painful hips, cough, hematuria and hematuria.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), infection ("infection"), urinary tract disorder ("urinary problems"), allergy to metals ("nickel sensitivity") and menstrual disorder ("abnormal cycles").The patient was treated with surgery (d&c).At the time of the report, the genital haemorrhage, autoimmune disorder, pelvic pain, infection, urinary tract disorder, allergy to metals and menstrual disorder outcome was unknown.The reporter considered allergy to metals, autoimmune disorder, genital haemorrhage, infection, menstrual disorder, pelvic pain, perforation and urinary tract disorder to be related to essure.The reporter commented: the essure device was placed into the left hand side with three or four coils left over after pushing them out and leaving the coils at the essure and placed on the left.Same thing vas done on the right they went in easily with no complications.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: post essure confirmation of blocked tubes.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ("migration/perforation"), genital haemorrhage ("bleeding") and autoimmune disorder ("autoimmune-like symptoms") in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included gestational diabetes, uti, anemia, epigastric pain, nausea, vomiting, bloody stool, dysuria, pains in legs, lethargy, painful feet, painful hips, cough, hematuria and hematuria.On (b)(6) 2012, the patient had essure inserted.On an unknown date, the patient experienced perforation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), autoimmune disorder (seriousness criterion medically significant), pelvic pain ("pain"), infection ("infection"), dysuria ("urinary problems"), allergy to metals ("nickel sensitivity") and menstrual disorder ("abnormal cycles").The patient was treated with surgery (d&c).At the time of the report, the genital haemorrhage, autoimmune disorder, pelvic pain, infection, dysuria, allergy to metals and menstrual disorder outcome was unknown.The reporter considered allergy to metals, autoimmune disorder, dysuria, genital haemorrhage, infection, menstrual disorder, pelvic pain and perforation to be related to essure.The reporter commented: the essure device was placed into the left hand side with three or four coils left over after pushing them out and leaving the coils at the essure and placed on the left.Same thing vas done on the right they went in easily with no complications.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2013: post essure confirmation of blocked tubes.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2019: quality safety evaluation of ptc.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: 8389043
• MDR Text Key: 137790733
• Report Number: 2951250-2019-00993
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Other