• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31105
Device Problem Flaked (1246)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/20/2015
Event Type  Injury  
Event Description

Physician reported that after placement of mesh laparoscopic, he sutured the mesh to the body around the edges of the mesh. While suturing, the omega-3-fatty-acid coating started flaking off.

 
Manufacturer Narrative

(b)(4). Upon completion of the investigation into this event a follow up report will be submitted.

 
Manufacturer Narrative

Investigation: lot history and sterilization records were reviewed. All in-process inspections and testing including but not limited to fourier-transform infrared spectrophotometry (ftir), coating density and pre and post sterile pouch peel. All raw materials met all incoming testing and inspections. The sterilization records were reviewed and passed. Review shows that this lot met all acceptance criteria for lot release. Clinical evaluation: clinical evaluation: c-qur mosiac mesh has a non-continuous coating derived from a biological oil composed of fatty acids, lipids and glycerides (bao bioabsorbable oil coating). It has a coating that is absorbable by the body. The fixation technique, method and products used are left solely to the discretion of the surgeon to optimize clinical outcomes. The instructions for use state under adverse reaction, 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MOSAIC
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 Key4947144
MDR Text Key6034657
Report Number1219977-2015-00199
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device EXPIRATION Date05/27/2018
Device MODEL Number31105
Device Catalogue Number31105
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/16/2015
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: 07/28/2015 Patient Sequence Number: 1
-
-