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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 31202
Device Problem Retraction Problem (1536)
Patient Problem Hernia (2240)
Event Date 06/17/2015
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation, a follow up report will be submitted.
 
Manufacturer Narrative
Investigation: the lot history and sterilization records were reviewed. All records showed that the product was manufactured to specifications. The following testing was required, and performed for this product: analysis of fish oil, fourier-transform infrared spectrophotometry (ftir) testing for coated mesh panels, suture retention and ball burst testing of bare mesh panels, and stitch strength testing. The analysis of fish oil showed that all requirements for chemical composition met acceptance criteria. The manufacturing records, inspection records, and sterilization records showed no non conformances or deviations. Based on the lot history review, there are no indications that the product was responsible for the incident reported. Clinical evaluation: mesh may contract due to position, body habitus, technical error, inadequate suture fixation and/or inadequate overlap. All of which may cause separation of the mesh from the abdominal wall increasing the possibility of complications. The compromised patient undergoing a second surgery for explant has increased risks. The instructions for use state complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions.
 
Event Description
Physician did a surgery laparoscopically to repair a recurrent hernia and found the previously placed mesh had retracted, shrunk, and was hard. The additional hernia was repaired with an additional piece of mesh. The previous mesh was removed. The patient was discharged in good condition.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH
Manufacturer Contact
theresa morin
5 wentworth drive
hudson, NH 03051
6038645237
MDR Report Key4867643
MDR Text Key13468255
Report Number1219977-2015-00165
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 Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date10/31/2016
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10910297
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received07/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2013
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: 06/24/2015 Patient Sequence Number: 1
Treatment
PERMANENT SUTURES
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