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

Event Date 01/02/2012

Event Type  Other  

Manufacturer Narrative

The device product code and lot number were not provided in the letter, therefore no lot history review was conducted. No conclusion regarding the reported event was possible with the limited information that was provided.

Event Description

Pt had a ventral hernia repair in (b)(6) 2011 at (b)(6). Pt. Stated, "there were no problems with this procedure or mesh". On (b)(6) 2011, while on holiday in (b)(6), pt. Experienced continuous vomiting. He was admitted to (b)(6) on (b)(6) 2011, with a diagnoses of a partially blocked colon and reactivated hernia. Pt. Had interventional surgery on (b)(6) 2012. Mesh was totally detached and "had wrapped around a series of colons and 'strangled' them. ".

• Brand Name: C-QUR MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; 5 wentworth dr.; hudson NH 03051
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson , NH 03051 ; 6038801433
• MDR Report Key: 2519804
• Report Number: 1219977-2012-00007
• Device Sequence Number: 1
• Product Code: FTL
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/28/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Service Personnel
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 03/15/2012
• 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: 03/28/2012 Patient Sequence Number: 1