MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INTEPRO Y-MESH; MESH, SURGICAL, GYNECOLOGIC

Catalog Number 72404000

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/15/2014

Event Type  malfunction  

Event Description

The patient had a procedure for an exploratory laparotomy with removal of pelvic mesh and drainage of pelvic abscess.The vaginal exam was done under anesthesia and cystourethroscopy.

• Brand Name: INTEPRO Y-MESH
• Type of Device: MESH, SURGICAL, GYNECOLOGIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS; 10700 bren road west; minnetonka, MN 55343
• MDR Report Key: 5406572
• MDR Text Key: 37367630
• Report Number: 5406572
• Device Sequence Number: 1
• Product Code: OTP
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 72404000
• Device Lot Number: 830754
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2016
• 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