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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Doctor reported having drainage and infection complications with patients implanted with mesh during ventral hernia repair procedure.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number or sample was provided. Requests for additional information were unsuccessful. 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. This may result in redness, drainage, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infections include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. Most ssis can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required to treat the ssi. Surgical standards include the use of sterile technique. Ineffective anti-microbial coating and introduction of foreign material may also be causes for wound infections. 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, and hematoma.
 
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Brand NameC-QUR MESH
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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5392689
MDR Text Key36897397
Report Number1219977-2016-00018
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2016
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2016
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: 01/27/2016 Patient Sequence Number: 1
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