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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION C-QUR MESH V PATCH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORPORATION C-QUR MESH V PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Lot Number 10752171075
Device Problems Retraction Problem (1536); Structural Problem (2506)
Patient Problems Failure of Implant (1924); Hernia (2240)
Event Date 08/27/2019
Event Type  Injury  
Event Description
Chronic abdominal pain since ventral hernia repair with atrium c-qur mesh in 2011 requiring multiple ed / hosp admissions, ct imaging, multiple medications. Surgery was done on (b)(6) 2019 for c-qur mesh removal, and redo hernia repair with mesh. Operative findings revealed that the c-qur mesh retracted into a mesh ball. Fda safety report id (b)(4).
 
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Brand NameC-QUR MESH V PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
MDR Report Key9391819
MDR Text Key168466423
Report NumberMW5091357
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number10752171075
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/27/2019 Patient Sequence Number: 1
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