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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 31201
Device Problem Contamination (1120)
Patient Problem Unspecified Infection (1930)
Event Date 11/05/2015
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted following the investigation into this event.
 
Event Description
Received report that patient developed infection following hernia surgery.
 
Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including seal strength testing on both the pre-and-post-sterile atrium-applied packaging. 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 in your body. Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. Most surgical site infections can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required to treat the ssi or explant the mesh. 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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5364722
MDR Text Key35917197
Report Number1219977-2016-00005
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
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 01/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model Number31201
Device Catalogue Number31201
Device Lot Number216214
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 Received01/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2014
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: 01/13/2016 Patient Sequence Number: 1
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