MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Adhesion(s) (1695)

Event Type  Injury  

Event Description

Received an article published in the surgical endoscopy, titled "prospective evaluation of adhesion characteristics to intraperitoneal mesh and adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair." per the article, "the purpose of this study was to characterize te adhesion characteristics of absorbable and nonabsorbable-barrier-coated meshes and to report adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair.Per the article, five patient presented with adhesion.

Manufacturer Narrative

A thorough investigation was not able to be performed as no product code, lot number, sample or additional information were provided.According to the article, the purpose of this study was to characterize the adhesion characteristics of absorbable - and nonabsorbable-barrier-related complications during laparoscopic re-exploration after prior ventral hernia repair.Multiple attempts were made to contact the authors of the study in order to request additional information but they were unsuccessful.

• Brand Name: C-QUR MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4072095
• MDR Text Key: 4825931
• Report Number: 1219977-2014-00246
• 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: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/29/2014
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention