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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 31202
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/12/2015
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted. Related reports: 1219977-2015-00195, 1219977-2015-00196, 1219977-2015-00197, 1219977-2015-00198.
 
Event Description
Received report that patient acquired an infection. Cultures were taken and antibiotics given. Mesh was explanted.
 
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), and ball burst conducted on the mesh at incoming and in-process ftir testing of the cured coated panel. Medical record review: a review of limited medical records revealed that the c-qur v-patch was explanted due to a suspicion of a chronically infected mesh. Cultures revealed scant growth of s. Lugdunensis which requires aggressive treatment in order to prevent more significant complications and s. Epidermidis which is part of normal human flora. Clinical evaluation: any surgery that causes a break in the skin can lead to a postoperative infection. 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. 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.
 
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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 Key5001769
MDR Text Key22942916
Report Number1219977-2015-00233
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number207133
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/28/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/20/2014
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: 08/13/2015 Patient Sequence Number: 1
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