• 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 MESH

  • 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 MESH Back to Search Results
Device Problem Material Erosion (1214)
Patient Problems Erosion (1750); Pain (1994); Hernia (2240); Reaction (2414)
Event Date 06/06/2012
Event Type  Injury  
Event Description
This mesh was implanted in (b)(6) 2012. After the surgery i was still in pain and had to have fluid drained from my abdomen due to the mesh erosion. The pain as well as the fluid building up in my abdomen continued. In (b)(6) 2014, i had to have the mesh removed as my body's rejection of the product. After the second surgery, i continued to be in pain and it was determined my hernia had grown back, leading to a second hernia repair operation in (b)(6) 2015.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameC-QUR MESH
Type of DeviceMESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP
MDR Report Key5341427
MDR Text Key35007159
Report NumberMW5058872
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/28/2015 Patient Sequence Number: 1
-
-