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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 Microbial Contamination of Device (2303)
Patient Problem Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Hernia surgery repair with mesh and on the tenth day post op infection. Infections led to deep sinus tract at surgery site. Patient went to a wound care center three days a week for eleven months. Mesh was removed. It was infected with klebsiella. Patient reported a large hole in the umbilical area three weeks post op which she had to insert a large wet to dry dressings. Reported pain and limited activity for several months post surgery and still unable to lift heavy objects.
 
Manufacturer Narrative
A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including testing for suture retention and ball burst conducted on the mesh at incoming. Fourier-transform infrared spectroscopy testing, in-process visual inspection with all requirements being met. 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. Other risks for surgical site infections (ssi) 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. Klebsiella infections refer to a type of healthcare-associated infection that is caused by the klebsiella bacteria. Most healthy people do not get klebsiella infections. However, people who are hospitalized and receiving treatment for other conditions may be susceptible to these infections. Klebsiella bacteria are usually spread through person-to-person contact. In healthcare settings, people who require long courses of antibiotics are more at risk for klebsiella infections. Fistulas are a known complication of incisional hernia repairs using prostheses. Risk factors include surgical technique used in fixation, presence of suture abscesses, and patient factors including obesity, diabetes mellitus, elder age and poor nutritional status. Prolonged pain can be defined as pain persisting for more than 3 months after surgery and it is a complication of many common procedures including hernia repair. Surgical technique can influence the development of chronic post-surgical pain and techniques to minimize nerve injury should be used whenever possible. Psychological factors may play a part in the development and success of treatment of post-operative pain. The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to, inflammation, infection and pain. " the fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes. 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. Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions and pain.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
5 wentworth drive
merrimack NH 03054
Manufacturer Contact
theresa morin
10 bowman drive
hudson, NH 03051
6038645237
MDR Report Key6176589
MDR Text Key62524441
Report Number1219977-2016-00257
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2015
Device Model Number31200
Device Catalogue Number31200
Device Lot Number10820954
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2012
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: 12/15/2016 Patient Sequence Number: 1
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