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

Model Number ESS305

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Menstrual Irregularities (1959); Abdominal Distention (2601); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('device breakage') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), amenorrhoea ("hormonal changes describe: lack of menstrual cycles"), mood swings ("mood swings"), tooth disorder ("dental problems") and abdominal distension ("bloating").Essure treatment was ongoing at the time of the report.At the time of the report, the device breakage, amenorrhoea, mood swings, tooth disorder and abdominal distension outcome was unknown.The reporter considered abdominal distension, amenorrhoea, device breakage, mood swings and tooth disorder to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-nov-2019: pfs received : events added- hormonal changes describe: lack of menstrual cycles & mood swings, dental problems, device breakage, bloating reporter added.No lot number or device sample was received in this case.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 device breakage ('device breakage') in an adult female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "essure confirmation test not conducted".On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), amenorrhoea ("hormonal changes describe: lack of menstrual cycles"), mood swings ("mood swings"), tooth disorder ("dental problems") and abdominal distension ("bloating").Essure treatment was ongoing at the time of the report.At the time of the report, the device breakage, amenorrhoea, mood swings, tooth disorder and abdominal distension outcome was unknown.The reporter considered abdominal distension, amenorrhoea, device breakage, mood swings and tooth disorder to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-nov-2019: quality safety evaluation of product technical complaint.Incident: no lot number or device sample was received in this case.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: 9303597
• MDR Text Key: 206956809
• Report Number: 2951250-2019-11358
• 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: 11/13/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other