MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE

Lot Number E24126

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Pregnancy (3193)

Event Date 06/13/2018

Event Type  Injury  

Event Description

Essure placed (b)(6) 2017; unplanned pregnancy occurred (b)(6) 2017; post hts hsg done (b)(6) 2018, and coils were not seen on imaging.

• Brand Name: ESSURE
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER HEALTHCARE LLC
• MDR Report Key: 7609501
• MDR Text Key: 111470828
• Report Number: MW5077892
• 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: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Lot Number: E24126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR