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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
Model Number 31528
Device Problem Insufficient Information (3190)
Patient Problems Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932)
Event Date 01/04/2012
Event Type  Injury  
Event Description
Allegedly, plaintiff also experienced inflammation, severe pain, chills, fever, abscesses, bowel obstruction, seroma, adhesions, vomiting, and chronic sinus tract.
 
Manufacturer Narrative
We are attempting to obtain further information into this event. Upon completion of the investigation a follow up report will be submitted.
 
Manufacturer Narrative
We are unable to fully investigate this event as no product code lot number or sample has been provided. We have made multiple attempts to obtain this information with no success. 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. Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. The instructions for use 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.
 
Manufacturer Narrative
Investigation: the lot history and sterilization records were reviewed. The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and pre & post sterile pouch peel. All raw materials met all incoming testing and inspections. The sterilization records results passed. Based on the lot records, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture. Related files: mw5041439, 1219977-2015-00276 and 1219977-2015-00277.
 
Event Description
Received report mw5041439 stating that a patient had an infection after being implanted with mesh in 2012.
 
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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
40 continental blvd
merrimack NH 03051
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key4919688
MDR Text Key110109448
Report Number1219977-2015-00186
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2015
Device Model Number31528
Device Catalogue Number31528
Device Lot Number10841987
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2012
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: 07/16/2015 Patient Sequence Number: 1
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