MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR TACHSHIELD MESH

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

We are unable to perform a full investigation as no sample, product code or lot number was available. Review of complaints does not show any similar reports related to a device failure. If any further details are provided a follow up report will be submitted. The other report is: 1219977-2014-00092.

Event Description

Received report of doctor has performed five cases using tachshield and had two events of infection.

• Brand Name: C-QUR TACHSHIELD MESH
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: theresa morin, mgr ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3687873
• MDR Text Key: 11666807
• Report Number: 1219977-2014-00093
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/01/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2014
• 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?: Yes
• Date Manufacturer Received: 02/01/2012
• 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: 02/28/2014 Patient Sequence Number: 1