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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 Device Operates Differently Than Expected (2913)
Patient Problems Adhesion(s) (1695); Pain (1994)
Event Type  Injury  
Event Description
This event is deemed reportable based on the allegations in a lawsuit which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medical mesh product.Plaintiff alleges that she had a mesh implanted for hernia repair and experienced pain and discomfort.Allegedly, the physician removed the mesh which adhered to both the omentum and the small bowel.Since this is a legal matter, the case has been turned over to legal counsel and further information 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 information comes to its attention.
 
Manufacturer Narrative
Upon completion of investigation into this event, a follow up report will be submitted.
 
Manufacturer Narrative
Additional information: a.2, b.5, b.7.Corrected informaton: d.4.
 
Event Description
Plaintiff allegedly also experienced recurrence and component separation.
 
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Brand Name
C-QUR MESH
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
MDR Report Key4275854
MDR Text Key16995050
Report Number1219977-2014-00377
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,other
Type of Report Initial,Followup,Followup
Report Date 11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/31/2013
Device Model Number31528
Device Catalogue Number31528
Device Lot Number10611131
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/11/2014
Initial Date FDA Received11/20/2014
Supplement Dates Manufacturer Received11/04/2019
04/06/2020
Supplement Dates FDA Received11/06/2019
04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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