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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH

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ATRIUM MEDICAL CORPORATION C-QUR MESH Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Tissue Damage (2104); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
I had to have hernia surgery and a mesh called c-qur mesh was implanted. After a while, at home, i started having terrible pain. I could not even stand up for more than 15 minutes at a time. I was told that i would have to have surgery to make repairs to my abdomen, and that most likely some of the mesh if not all, would have to be removed and replaced. After this surgery, things started to get even worse. I had to have another surgery which required 7 plus hours in surgery, to remove and repair damage which had been caused previously by the mesh.
 
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Brand NameC-QUR MESH
Type of DeviceC-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
MDR Report Key5341358
MDR Text Key35010345
Report NumberMW5058867
Device Sequence Number1
Product Code FTL
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
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