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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 31201
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 05/18/2016
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event. Related mdrs: 3011175548-2016-00003, 3011175548-2016-00004.
 
Event Description
Received a report of infection. Mesh was removed. Culture results were negative.
 
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. 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: an incarcerated hernia is a surgical emergency and occurs when a loop of bowel exits a weakening in the abdominal wall allowing the intestine to poke through the hole. The muscles in the area clamp down restricting circulation to that piece of intestine. This rapidly results in tissue death. Dead intestine releases all kinds of toxins into the blood stream which in turn causes septicemia and may ultimately result in death. A surgical emergency has a higher risk of adverse events than planned procedures. The surgeon's priority is to release the entrapped bowel and return it where it belongs, inside the abdominal cavity. This must be done before the tissue is permanently damaged. 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. "an incarcerated hernia is a surgical emergency and occurs when a loop of bowel exits a weakening in the abdominal wall allowing the intestine to poke through the hole. The muscles in the area clamp down restricting circulation to that piece of intestine. This rapidly results in tissue death. Dead intestine releases all kinds of toxins into the blood stream which in turn causes septicemia and may ultimately result in death. A surgical emergency has a higher risk of adverse events than planned procedures. The surgeon's priority is to release the entrapped bowel and return it where it belongs, inside the abdominal cavity. This must be done before the tissue is permanently damaged. 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 Key5775808
MDR Text Key48976404
Report Number3011175548-2016-00002
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 06/28/2016
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 Date07/31/2018
Device Model Number31201
Device Catalogue Number31201
Device Lot Number401737
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 Received07/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2015
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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