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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 11/16/2015
Event Type  Injury  
Manufacturer Narrative
Upon the completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Patient had a recurrent ventral hernia, which was repaired laparoscopically using mesh. Surgeon then performed wound debridement on (b)(6) 2015, as patient had pus coming from sinus next to umbilicus. Mesh was then removed and further debridement of wound occurred, as well as repair with bio-a (gore mesh). Cultured mesh, tissue and fluid and awaiting results.
 
Manufacturer Narrative
The lot history of was reviewed. Incoming inspection records show the bare mesh used to manufacture this lot passed all suture and ball burst strength requirements. The fish oil used to manufacture this lot passed incoming inspection, including fourier-transform infrared spectrophotometry (ftir) testing. The qc in-process testing completed for each sub-assembly met all release criteria including visual inspection, ftir, pouch peel and stitch strength analysis. Records show that the lot was sterilized acceptably. Based on the available lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture. The engineering evaluation did not find any defects on the mesh sample returned. The sample appeared intact and did exhibit the tissue ingrowth that was noted in the report from the hospital. Clinical evaluation: any surgery that causes a break in the skin can lead to a postoperative infection. Infections may occur 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. Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infection include elderly and/or overweight patients, smokers, and patients with weakened immune systems. Most surgical site infections can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required. 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 Key5235633
MDR Text Key31594404
Report Number1219977-2015-00329
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 11/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number210655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/19/2015 Patient Sequence Number: 1
Treatment
ABSORBABLE TACKS
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