MAUDE Adverse Event Report: BAYER HEALTHCARE, LLC ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Foreign Body In Patient (2687)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Essure (b)(6) 2008 placed fallopian tubes and device removed (b)(6) 2011.Device was found to be missing from one fallopian tube [l].Path report showed both devices on (b)(6) 2011.Pain continued with bleeding; hysterectomy (b)(6) 2011 - path report did not show and foreign objects.Patient had multiple radiology studies over the years with no retained items or broken pieces found (b)(6) 2021, exploratory lap due to ongoing issues with pain; found the tip of a foreign object [essure - not part of the coil - 2 mm].Fda safety report id # (b)(4).

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER HEALTHCARE, LLC
• MDR Report Key: 12916672
• MDR Text Key: 281739587
• Report Number: MW5105711
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 82 KG