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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL CORP. C-QUR MESH; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31531
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Adhesion(s) (1695); Inflammation (1932); Obstruction/Occlusion (2422)
Event Date 05/31/2015
Event Type  Injury  
Event Description
This event is deemed reportable based on the allegations in a potential lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product.It was alleged that the mesh was removed due to intraabdominal adhesions and mesh rejection.Since this is a potential legal matter, the case has been turned over to legal counsel and further info obtained through investigation or discovery may fall under the attorney/client and/or work product privilege.However, atrium will supplement this report as appropriate if additional info comes to its attention.
 
Manufacturer Narrative
Investigation: review of manufacturing and sterilization records found no issues during manufacture or sterilization.A review of the medical records revealed that the pt had an open repair of a midline incisional hernia from a prior abdominal surgery.
 
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Brand Name
C-QUR MESH
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
theresa morin
5 wentworth dr.
hudson, NH 03051
6038645237
MDR Report Key4600086
MDR Text Key21082963
Report Number1219977-2015-00059
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 02/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2013
Device Model Number31531
Device Catalogue Number31531
Device Lot Number10720966
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/19/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2010
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 Age62 YR
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