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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH
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ATRIUM MEDICAL CORP. C-QUR MESH Back to Search Results
Model Number 31528
Device Problem Entrapment of Device (1212)
Patient Problem Adhesion(s) (1695)
Event Date 02/24/2014
Event Type  Injury  
Event Description
During an unrelated abdominal surgery a surgeon noticed that there were adhesions to the mesh placed 18 months prior.Adhesions removed.No patient injury.
 
Manufacturer Narrative
We are in the process of performing the investigation and will submit the f/u report once the evaluation is completed.The other related report is 1219977-2014-00124.
 
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Brand Name
C-QUR MESH
Type of Device
MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
lori gosselin, sr qa splst
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key3839069
MDR Text Key4407376
Report Number1219977-2014-00162
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2015
Device Model Number31528
Device Catalogue Number31528
Device Lot Number10833791
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/02/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
Patient Weight96
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