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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL C-QUR MOSAIC MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31107
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Information (3190)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
Upon completion of the investigation a follow up report will be submitted.
 
Event Description
Surgeon used c-qur mosaic mesh for a lap ventral hernia. A few of the sorbafix tacks went through the entire mesh failing to fixate to the tissue. The mesh was left in the patient, as most of the tacks were fixated properly, 45 in total.
 
Manufacturer Narrative
No product was returned as part of the complaint as it was successfully implanted. No images of the sorbafix tacks were provided showing that they had gone through the mesh. A full review of all manufacturing lot history records was performed and no deficiencies were noted during the review. All product manufactured met the product requirements. Based on the product meeting all product quality and performance requirements atrium cannot conclude that the c-qur mosaic mesh was defective. Clinical evaluation: a ventral hernia is a bulge through an opening in the muscles of the middle of the abdomen. The hernia can occur at a past incision site (incisional), above the navel (epigastric), or other weak muscle sites (primary abdominal). C-qur mosaic is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. Adequate mesh fixation is required to minimize post-operative complications and recurrence. The fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes. Careful attention to suture/staple/tacker placement and spacing will help prevent excessive tension or disruption of the mesh material and/or underlying tissue. It is recommended that suture/staples/tackers be placed a minimum of 5 mm from the edge of the mesh for best results. The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs. The patient should be advised to contact the physician should an adverse reaction occur.
 
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Brand NameC-QUR MOSAIC MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7542087
MDR Text Key109182783
Report Number3011175548-2018-00522
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K121070
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 05/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/07/2020
Device Model Number31107
Device Catalogue Number31107
Device Lot Number424777
Other Device ID Number00650862311075
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 Received05/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2017
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: 05/24/2018 Patient Sequence Number: 1
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