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

Model Number ESS305

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

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

Event Date 10/09/2014

Event Type  malfunction  

Event Description

The essure disposable used for tubal ligation unraveled abnormally in the left fallopian tube.Instead of looking like a slinky, it looked like a coil of wire all rolled around in a ball.The second essure did not sit perfectly but was good, and left in the right fallopian tube.

• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas CA 95035
• MDR Report Key: 4180193
• MDR Text Key: 5158386
• Report Number: 4180193
• Device Sequence Number: 1
• Product Code: KNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ESS305
• Device Catalogue Number: ESS305
• Device Lot Number: A66685
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1