• 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 CORP. C-QUR V-PATCH MESH 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 CORP. C-QUR V-PATCH MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31202
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Date 02/28/2014
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Received a medwatch stating that patient underwent a repair of hernia. Patient reported pain, adhesions, infection, swelling, etc.
 
Manufacturer Narrative
Unable to obtain additional information as no phone number or email address were provided. Lot history records for this c-qur v-patch large were reviewed. The mesh rolls used to manufacture this c-qur mesh met specification for suture retention strength and ball burst strength. The lot records showed that the fish oil passed all analytical testing. Test records showed that the mesh coating had adequate crosslinking. Sterilization records were found to be complete and show that the lot was released. The packaged finished goods were tested pre and post sterile and met the pouch peel test acceptance requirements. Based on the available lot information, the device was manufactured according to the appropriate manufacturing procedures and met all required specifications for the device at the time of manufacture. There were no deviations or non-conformances noted during the course of this review. Clinical evaluation: any surgery that causes a break in the skin can lead to a postoperative infection. Doctors call these infections surgical site infections (ssis) because they occur on the part of the body where the surgery took place. Microorganisms can infect a surgical wound through various forms of contact, such as from the touch of a contaminated caregiver or surgical instrument, through microorganisms in the air, or through microorganisms that are already on or in your body and then spread into the wound. Any ssi may cause redness, delayed healing, fever, pain, tenderness, warmth or swelling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR V-PATCH MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
hudson NH
Manufacturer Contact
theresa morin
40 continental blvd
merrimack, NH 03054
6038645237
MDR Report Key4818451
MDR Text Key13392737
Report Number1219977-2015-00162
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K080688
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Type of Report Initial,Followup,Followup
Report Date 06/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date11/30/2014
Device Model Number31202
Device Catalogue Number31202
Device Lot Number10808442
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2011
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: 06/03/2015 Patient Sequence Number: 1
-
-