MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MOSAIC; MESH, SURGICAL, POLYMERIC

Model Number 31106

Device Problem Hole In Material (1293)

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

Event Date 01/06/2017

Event Type  malfunction  

Event Description

When the surgeon tried to pass a suture through the middle of the product, the product had a hole torn in it.

• Brand Name: C-QUR MOSAIC
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth dr.; hudson NH 03051
• MDR Report Key: 6348758
• MDR Text Key: 67941052
• Report Number: 6348758
• Device Sequence Number: 1
• Product Code: FTL
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/22/2019
• Device Model Number: 31106
• Device Catalogue Number: 31106
• Device Lot Number: 407066
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 59 YR
• Patient Weight: 124