MAUDE Adverse Event Report: BAYER HEALTHCARE; INSERT, TUBAL OCCLUSION

Model Number ESS306

Device Problems Misfire (2532); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 11/25/2015

Event Type  malfunction  

Event Description

Device would not roll back to disclose copper coil and fired deep into fallopian tube.

• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE; 1011 mccarthy blvd; miplas CA 95035
• MDR Report Key: 5326424
• MDR Text Key: 34313798
• Report Number: 5326424
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2015,12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ESS306
• Device Lot Number: DO6939
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 61