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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Adhesion(s) (1695)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, adhesion characteristics of mesh placed intraperitoneally and adhesiolysis-related complications during laparoscopic repair are associated with unique properties of the mesh and/or barrier.
 
Event Description
Received article titled "prospective evaluation of adhesion characteristics to intraperitoneal mesh and adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair. " this study reported the adhesion characteristics of absorbable- and nonabsorbable-barrier-coated meshes and related complications. The study included 69 patients with re-do after prior mesh placement for ventral hernia repair. Per the study, five patients had mild adhesions.
 
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Brand NameC-QUR MESH
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
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key5528549
MDR Text Key41215068
Report Number1219977-2016-00049
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,study
Reporter Occupation
Type of Report Initial
Report Date 03/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2016
Was Device Evaluated by Manufacturer? No Answer Provided
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: 03/28/2016 Patient Sequence Number: 1
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