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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORP C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event. Related mdrs: 3011175548-2016-00002, 3011175548-2016-00003.
 
Event Description
Received a report of infection. Mesh was removed. Culture grew scedosporium apiospermum.
 
Manufacturer Narrative
A review of lot history and sterilization records was performed. The finished good and subassembly lots passed all in-process inspections and testing including but not limited to fourier transform infrared spectroscopy and seal strength on pre & post sterile pouches. All raw materials met all incoming testing and inspections. Review shows that this lot met all sterilization and manufacturing acceptance criteria for lot release. 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. Any surgical site infection (ssi) may cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Most ssis can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required. The ifu 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 MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP
40 continental blvd.
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5775816
MDR Text Key48975688
Report Number3011175548-2016-00004
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090909
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 06/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model Number31200
Device Catalogue Number31200
Device Lot Number401129
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 Received07/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2015
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: 07/07/2016 Patient Sequence Number: 1
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