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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORP C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
 
Event Description
Mesh was implanted for hernia repair. Patient came back to hospital complaining about pain. Doctor said that after investigation and inspection of mesh there was puss surrounding mesh implant and it was infected. Mesh was removed. Testing was done on mesh revealed e. Coli. Doctor stated that the mesh having already been infected before use had very little likelihood since he has never seen this before nor heard of this before but he couldn't tell for sure how it happened.
 
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 pre & post sterile pouch peel. 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: escherichia coli (e. Coli) bacteria normally live in the intestines of people and animals. Most e. Coli are harmless and actually are an important part of a healthy human intestinal tract. However, some e. Coli are pathogenic, meaning they can cause illness and infection. The types of e. Coli that can cause illness can be transmitted through contaminated water or food, or through contact with animals or persons. When strains of escherichia coli (e. Coli) bacteria, are outside their normal habitat of the gut, they can cause serious infections, several of which can be fatal. E. Coli is a common cause of infections in surgical wounds, especially those following operations on the abdomen where it is often found mixed with other gut bacteria, but it can also be found in other post-operative sites. 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. Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infection include elderly and/or overweight patients. Most ssis can be treated successfully with antibiotic medications. Sometimes additional surgery or procedures may be required to treat the infection. 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 CORP
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03054
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5390825
MDR Text Key36895845
Report Number1219977-2016-00014
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080688
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 01/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2018
Device Model Number31200
Device Catalogue Number31200
Device Lot Number4008873
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2015
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: 01/26/2016 Patient Sequence Number: 1
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