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

Model Number ESS305

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2015

Event Type  malfunction  

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER HEALTHCARE LLC; 1011 mccarthy blvd; milpitas, CA 95035
• MDR Report Key: 4597943
• Report Number: 4597943
• Device Sequence Number: 1
• Product Code: HHS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: ESS305
• Device Lot Number: C91742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 66