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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31628
Device Problem Insufficient Information (3190)
Patient Problem Foreign Body Reaction (1868)
Event Date 07/24/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). Upon completion of the investigation into this event a follow up report will be submitted.
 
Manufacturer Narrative
Investigation: the lot history was reviewed. Incoming inspection records show the bare mesh used to manufacture this lot passed all suture and ball burst strength test requirements. The qc in-process testing completed for each sub-assembly met all acceptance criteria including visual inspection, fourier-transform infrared spectrophotometry, weld strength, and pouch peel strength. Records show that the lot was sterilized acceptably. Based on the available lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture. There were no deviations or non-conformances noted during the course of this review. Clinical evaluation: inflammation is the biological response to something harmful or irritating that affects a part of our body. The signs and symptoms of inflammation, specifically acute inflammation, show that the body is trying to heal itself. Inflammation does not mean infection, even when an infection causes inflammation. Infection is caused by a bacterium, virus or fungus, while inflammation is the body's response to it. Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue. In the event of improper fixation and placement adverse reactions may occur such as inflammation and pain and may require explant of the mesh. The instructions for use state, "an adverse reaction may occur with the use of any surgical mesh when placed in direct contact with the viscera. ".
 
Event Description
Mesh was implanted in patient 10 weeks ago - 3 weeks post op they developed a redness on the skin. Wound had healed well otherwise. Patient was treated with antifungal, clindamycin, fluclox - stopped antibiotics 24 hour pre op and redness decreased. Performed biopsy of skin and microbiology has all come back negative for infection.
 
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Brand NameC-QUR TACSHIELD
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
5 wentworth drive
hudson, NH 03051
6038645237
MDR Report Key4947161
MDR Text Key13963765
Report Number1219977-2015-00200
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative,company represent
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2015
Device Model Number31628
Device Catalogue Number31628
Device Lot Number10826828
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2012
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: 07/28/2015 Patient Sequence Number: 1
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