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

Model Number ESS305

Device Problems Difficult to Remove (1528); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); 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 ('medical device removal') in a female patient who had essure inserted.Other product or product use issues identified: device difficult to use "improper removals".On an unknown date, the patients had essure inserted.On an unknown date, the patients underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media device difficult to remove, medical device removal.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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of medical device removal ('medical device removal') in a female patient who had essure inserted.Other product or product use issues identified: device difficult to use "improper removals".On an unknown date, the patients had essure inserted.On an unknown date, the patients underwent medical device removal (seriousness criteria medically significant and intervention required).The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the medical device removal outcome was unknown.The reporter considered medical device removal to be related to essure.Concerning the injuries reported in this case, the following ones were reported via social media- device difficult to remove, medical device removal.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 16-dec-2019: quality-safety evaluation of ptc (product technical complaint).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: 9460775
• MDR Text Key: 178769103
• Report Number: 2951250-2019-12185
• 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: 12/20/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention