MAUDE Adverse Event Report: BAYER ESSURE PERMANENT BIRTH CONTROL

Model Number ESS305

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

Introducer for bayer essure permanent birth control was bent upon opening, thereby not allowing the device to pass.Replaced with one of the same lot number with no further issues noted.

• Brand Name: ESSURE PERMANENT BIRTH CONTROL
• Type of Device: ESSURE
• Manufacturer (Section D): BAYER; whippany NJ 07981
• MDR Report Key: 6996123
• MDR Text Key: 90974684
• Report Number: MW5073100
• Device Sequence Number: 1
• Product Code: HHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: ESS305
• Device Catalogue Number: ESS305
• Device Lot Number: HE012XW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2017
• 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 Age: 34 YR