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Model Number 31536
Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Code Available (3191)
Event Date 06/09/2013
Event Type  Injury  
Manufacturer Narrative
This event is under investigation and upon completion, a f/u report will be submitted.
Event Description
The dr implanted the original sheet of c-qur mesh in an open procedure. Wand could not get adequate peritoneal coverage and nor re-approximate the facia. Dr could not get the mesh to sit completely flat so used a technique which involves splitting the mesh and pleating it over and suturing it back together as a means of tightening it once it has been fixated lateral to the defect. The dr has been using c-qur mesh to do similar procedures for years. This time had to go back in only 3 days later for reasons that not make clear. When first saw the mesh the 03fa adhesion barrier remained intact. At some point during the second procedure noticed that a large portion of the adhesion barrier had simply fallen off of the mesh and was resting on bowel. Dr then removed the uncoated c-qur mesh and replaced it with a new piece of c-qur mesh. The dr felt the issue may have been related to the folding of the mesh so tried to keep the second piece as flat as possible in order to avoid a similar result. Dr reported the next piece has worked well.
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Brand NameC-QUR MESH
Manufacturer (Section D)
hudson NH
Manufacturer Contact
theresa morin, mgr.
5 wentworth dr.
hudson, NH 03051
MDR Report Key3282516
MDR Text Key11009579
Report Number1219977-2013-00121
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/31/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2016
Device Model Number31536
Device Catalogue Number31536
Device Lot Number10878121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/31/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2013
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: 08/06/2013 Patient Sequence Number: 1