MAUDE Adverse Event Report: BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM; MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE

Model Number M0068502110

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 01/30/2018

Event Type  malfunction  

Event Description

When opening the advantage fit system box to place items on the sterile field, it was noted that the box contained only the obturator but no mesh.Another box was obtained to use.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7240476
• MDR Text Key: 98974892
• Report Number: 7240476
• Device Sequence Number: 1
• Product Code: OTN
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/09/2020
• Device Model Number: M0068502110
• Device Lot Number: 21368395
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• 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: 64 YR