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

Model Number ESS305

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

Patient Problems Pain (1994); 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 ('removal') in an adult female patient who had essure inserted for female sterilisation.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (surgery to remove essure).Essure was removed on (b)(6) 2018.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation 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 ('removal').In an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced abscess ("abscess").The patient was treated with surgery (surgery to remove essure).Essure was removed on (b)(6) 2018.At the time of the report, the medical device removal and abscess outcome was unknown.The reporter considered abscess and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2020, plaintiff fact sheet received: added event: abscess.Based on the available information.A review of our complaint records and other relevant data was conducted.Any new and reportable information that becomes available from our investigation, 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 ('removal') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and experienced abscess ("abscess").The patient was treated with surgery (surgery to remove essure).Essure was removed on (b)(6) 2018.At the time of the report, the medical device removal and abscess outcome was unknown.The reporter considered abscess and medical device removal to be related to essure.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-jul-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pelvic pain') in an adult female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2011, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abscess ("abscess"), dysmenorrhoea ("dysmenorrhea"), menorrhagia ("menorrhagia") and dyspareunia ("dyspareunia").The patient was treated with surgery (surgery to remove essure/laparoscopic assisted vagina1 hysterectomy/bilateral salpingectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, abscess, dysmenorrhoea, menorrhagia and dyspareunia outcome was unknown.The reporter considered abscess, dysmenorrhoea, dyspareunia, menorrhagia and pelvic pain to be related to essure.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: pelvic pain, dysmenorrhea, menorrhagia and dyspareunia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 18-mar-2021: mr received.Reporter information , auto-narrative supplement added.Event : "removal" updated to "pelvic pain'.Events dysmenorrhea, menorrhagia and dyspareunia added.Based on the available information, a review of our complaint records and other relevant data was 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: 10216209
• MDR Text Key: 197108824
• Report Number: 2951250-2020-10140
• 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,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention