MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR V-PATCH

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Received report that out of 157 patients, three had infection.

Manufacturer Narrative

There are three events of infection reported in this file as no specific details have been provided for any of the three events.Three reports submitted.Other two reports are 1219977-2014-00010 and 1219977-2014-00014.We are unable to investigate this report as the product code, lot number and sample are not available.If further information is obtained a follow up report will be submitted.

• Brand Name: C-QUR V-PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: theresa morin, mgr ; 5 wentworth drive; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3632504
• MDR Text Key: 3990602
• Report Number: 1219977-2014-00013
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2014

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: 01/24/2014
• Initial Date FDA Received: 02/06/2014
• 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): Other