• 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 V-PATCH 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 V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the investigation into this event has been completed.
 
Event Description
Patient underwent open surgical repair of a midline upper abdominal wall (epigastric) hernia. The peritoneum was entered intra operatively. Mesh was inserted to close the hernia defect. Port operatively there was some small seroma but no other complications. After almost a year, because of ongoing epigastric pain the client underwent further surgery.
 
Manufacturer Narrative
Additional information added to model #/lot # and device manufacture date. A review of the manufacturing lot history and sterilization records was conducted. All in-process specifications and release criteria were met, including testing for suture retention and ball burst conducted on the mesh at incoming. Fournier transform infrared spectroscopy testing and coating density of the cured omega-3 fatty acids coated panels and seal strength testing on both the pre-and-post-sterile atrium-applied packaging seals were also performed, with all requirements being met. Clinical evaluation: it was reported that a patient had adverse events occur after implant of surgical mesh requiring surgical intervention. Abdominal adhesions are bands of fibrous tissue that can form between abdominal tissues and organs after abdominal surgery. Normally, internal tissues and organs have slippery surfaces, preventing them from sticking together as the body moves. However, adhesions cause tissues and organs in the abdominal cavity to stick together. Surgery in the lower abdomen and pelvis carries an even greater chance of abdominal adhesions which can become larger and tighter as time passes, sometimes causing problems years after surgery. Prolonged pain can be defined as pain persisting for more than 3 months after surgery and is a complication of many common procedures including hernia repair. Surgical technique can influence the development of chronic post-surgical pain and techniques to minimize nerve injury should be used whenever possible. A seroma is a collection of fluid under the skin. Usually it occurs at the site of a surgical incision and may form about one to two weeks after surgery. It may look like a swollen lump and feel tender or sore and there may be drainage. If you have a large seroma or it is causing pain, the doctor may drain it. Seromas can return and may need to be drained multiple times. The instructions for use state, "complications may occur with the use of any surgical mesh including, but not limited to pain, seroma and mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs. " the fixation technique, method, and products used are left to the discretion of the surgeon to optimize clinical outcomes. Careful attention to proper fixation techniques and placement of the mesh product should be taken to help prevent excessive tension or disruption between the mesh material and connective tissue. Placing surgical mesh in contact with the intestines and/or improper surgical fixation can increase incidence of adhesions and pain.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key6142121
MDR Text Key61345505
Report Number1219977-2016-00245
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/30/2014
Device Model Number31200
Device Catalogue Number31200
Device Lot Number10752128
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 Received12/05/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-