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

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("removal of her uterus, cervix and tubes") and abdominal adhesions ("intestinal adhesions") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.In 2023 she underwent medical device removal (seriousness criteria hospitalisation and intervention required).Essure was removed on an unknown date in the same year.On an unknown date, the patient had essure inserted.On an unknown date she experienced abdominal adhesions (seriousness criteria hospitalisation and medically important).The patient was treated with surgery (hysteroctomy & bilateral salpingectomy and abdominal surgery).At the time of the report, the outcome of medical device removal was unknown.No causality assessment was received for essure with regard to medical device removal or abdominal adhesions.The reporter commented: she request information regardng essure package leaflet.It was an abdominal surgery similar to a caesarean section, although i had never had a caesarean section before as my previous births had been normal.During my recovery, i developed intestinal adhesions that caused severe obstructions.I had to undergo another surgery in (b)(6) 2023, which took me to the intensive care unit (icu).Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 29-sep-2023: event adverse event nos is replaced with medical device removal.Event intestinal adhesion was added.Essure removal surgery details updated.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.

Manufacturer Narrative

This spontaneous case was reported by a consumer and describes the occurrence of medical device removal ("removal of her uterus, cervix and tubes") and abdominal adhesions ("intestinal adhesions") in a female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.In 2023 she underwent medical device removal (seriousness criteria hospitalisation and intervention required).Essure was removed on an unknown date in the same year.On an unknown date, the patient had essure inserted.On an unknown date she experienced abdominal adhesions (seriousness criteria hospitalisation and medically important).The patient was treated with surgery (hysterectomy & bilateral salpingectomy and abdominal surgery).At the time of the report, the outcome of medical device removal was unknown.No causality assessment was received for essure with regard to medical device removal or abdominal adhesions.The reporter commented: she request information regarding essure package leaflet.It was an abdominal surgery similar to a caesarean section, although i had never had a caesarean section before as my previous births had been normal.During my recovery, i developed intestinal adhesions that caused severe obstructions.I had to undergo another surgery on (b)(6) 2023, which took me to the intensive care unit (icu).Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 13-oct-2023: 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 17885323
• MDR Text Key: 325076574
• Report Number: 2951250-2023-03047
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Hospitalization
• Patient Sex: Female