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

Model Number ESS305

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Event Description

"ntaneous" case was reported by a non-health professional and describes the occurrence of medical device removal ("my daughter recently had to have them removed due to major health issues") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required), device breakage ("have found that pieces have broken off and moved") and complication of device removal ("have found that pieces have broken off and moved").The patient was treated with surgery.Essure was removed.At the time of the report, the medical device removal, device breakage and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage and medical device removal to be related to essure.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

Manufacturer Narrative

Spontaneous case was reported by a non-health professional and describes the occurrence of device breakage ("have found that pieces have broken off and moved") and medical device removal ("my daughter recently had to have them removed due to major health issues") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criterion medically significant), medical device removal (seriousness criteria medically significant and intervention required) and complication of device removal ("have found that pieces have broken off and moved").The patient was treated with surgery.Essure was removed.At the time of the report, the device breakage, medical device removal and complication of device removal outcome was unknown.The reporter considered complication of device removal, device breakage 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 15-nov-2018: quality safety evaluation of ptc incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental 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: 7813406
• MDR Text Key: 118154969
• Report Number: 2951250-2018-03699
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention