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

Model Number 31202

Device Problem Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 01/28/2015

Event Type  Injury  

Event Description

Surgeon placed a large mesh in the patient for open umbilical hernia.It was removed because it did not lay flat.Another mesh was implanted.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be submitted.

• Brand Name: C-QUR V-PATCH MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4493696
• MDR Text Key: 5351892
• Report Number: 1219977-2015-00038
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 10904282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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
• Patient Age: 35 YR