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

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

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

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.

• 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
• 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 Outcome(s): Required Intervention