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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
Report received from of infection with mesh that had to be explanted. Cultures were done on explants and they showed skin flora along with other bacteria.
 
Manufacturer Narrative
(b)(4). Upon completion of the investigation into this event a follow up report will be submitted. Related reports:(b)(4).
 
Manufacturer Narrative
Investigation: a review of the lot history and sterilization records was conducted. No deviations were noted or found in any of the documentation and all release criteria was met, including testing for suture retention (coarse and wale), fourier-transform infrared spectrophotometry (ftir),release criteria and sterilization records. This lot met all manufacturing and quality release criteria including ftir of mesh, suture and ball burst, stitch strength and pouch peel specifications prior to sending to the sterilizer. The sterilization record review passed all acceptance criteria. Medical record review: a review of limited medical records reveal that the mesh was explanted due to a suspicion of a chronically infected mesh. Cultures revealed no bacterial growth, either aerobic or anaerobic. Clinical evaluation: microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound. Infections may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. 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. The instructions for use precaution against handling of the mesh without clean sterile gloves and instruments. It states in adverse reactions, "complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines) and organs.
 
Event Description
Patient was being treated for ventral hernia repair.
 
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Brand NameC-QUR V-PATCH
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 Key4942117
MDR Text Key15128727
Report Number1219977-2015-00197
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K080688
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 07/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Model Number31200
Device Catalogue Number31200
Device Lot Number212999
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 Received08/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2014
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: 07/27/2015 Patient Sequence Number: 1
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