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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 Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 08/12/2015
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
 
Event Description
Received a report of a possible infection less than 30 days after mesh was implanted.
 
Manufacturer Narrative
Investigation: a review of the manufacturing lot history and sterilization records for the reported lot was conducted. All in-process specifications and release criteria were met, including testing for suture retention (course and wale), residual lubricant testing by gc, and ball burst conducted on the mesh at incoming. Fourier-transform infrared spectrophotometer testing of the cured fish oil coated panels, stitch strength testing of the sewn pallet, and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met. 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. 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. Any infection will cause redness, delayed healing, fever, pain, tenderness, warmth, or swelling. Other risks for infection include a compromised patient, elderly and/or overweight patients, weakened immune systems and diabetes. 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
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
5 wentworth drive
hudson, NH 03051
6038645237
MDR Report Key5056737
MDR Text Key25021468
Report Number1219977-2015-00264
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 08/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model Number31202
Device Catalogue Number31202
Device Lot Number217490
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 Received09/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2014
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: 09/04/2015 Patient Sequence Number: 1
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