MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Event Date 09/20/2012

Event Type  Injury  

Event Description

Home pt reported that she had hernia (belly) surgery using c-qur mesh on (b)(6) 2010. On (b)(6) 2012 was admitted for bowel movement difficulties. Surgery was performed to remove the large intestine. Mesh had grown around the colon. Pt now must use a "bag" for collection.

Manufacturer Narrative

A final report will be submitted upon the completed investigation into this event.

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: theresa morin, capa manager ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3405675
• MDR Text Key: 3903526
• Report Number: 1219977-2013-00141
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/25/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/07/2013 Patient Sequence Number: 1