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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31128
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2017
Event Type  malfunction  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
The surgeon had completed the implantation of the mesh and he noticed the mesh coating on his gloves. There was no damage noted to the mesh when removing it from the packaging. Staff reported that approximately half of the coating came off but it was in patches and not in localized areas.
 
Manufacturer Narrative
All in-process specifications and release criteria were met, including pre-and-post-sterile seal strength testing on the packaging, fourier-transform infrared spectroscopy and coating density testing on the cured coated c-qur mosaic panel, and visual inspection of the coating of the cut sample. Ball burst, suture retention (course and wale directions), and ftir testing were conducted on the polypropylene mesh material at incoming and all acceptance criteria was also met. Clinical evaluation: c-qur mosaic mesh is a sterile, knitted polypropylene monofilament mesh material with a non-continuous coating derived from biological oil composed of fatty acids, lipids and glycerides (bao bioabsorbable oil coating). This product is intended for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material. The bao coating is absorbable by the body. If in the event the coating does flake or come off during a procedure it would cause no harm to the patient, the mesh would then become the equivalent of bare mesh. The instructions for use state under adverse reaction, that complications may occur with the use of any surgical mesh include, but are not limited to, 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 MOSAIC
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
10 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6431407
MDR Text Key70770068
Report Number3011175548-2017-00010
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/24/2018
Device Model Number31128
Device Catalogue Number31128
Device Lot Number401722
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 Received04/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/27/2015
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: 03/24/2017 Patient Sequence Number: 1
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