• 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 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 CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31528
Device Problem Insufficient Information (3190)
Patient Problem Rash (2033)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation into this event.
 
Event Description
Received report of a patient developing a rash that would not clear up three months after implanting mesh.
 
Manufacturer Narrative
We are unable to fully investigate this event as no lot number or sample was provided. Complainant has not answered requests for additional information. Clinical evaluation: rash is not a specific diagnosis. Instead it means skin inflammation and discoloration that changes the way the skin looks. It is a general term that describes an inflammation of the skin. A rash can have many causes and occurs in many forms. It usually involves an itchy rash on swollen, reddened skin. A rash is a common condition that's not contagious and usually isn't life-threatening. In a certain percentage of people with a skin reaction the cause may not be readily apparent or characterized. In these cases, the origin of the condition is said to be idiopathic. The instructions for use state in adverse reactions complications that may occur with the use of any surgical mesh include inflammation and infection. A skin reaction may be due to a foreign body response, or an introduction of bacteria or even environmental factors.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5219060
MDR Text Key30983215
Report Number1219977-2015-00326
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number31528
Device Catalogue Number31528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/11/2015 Patient Sequence Number: 1
-
-