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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 31533
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Pain (1994); Obstruction/Occlusion (2422); No Information (3190)
Event Type  Injury  
Event Description
Plaintiff allegedly also experienced severe and chronic pain, small bowel obstruction, adhesions and mental pain.
 
Manufacturer Narrative
We are unable to fully investigate this report as no product number, lot number or sample was provided.
 
Event Description
This event is deemed reportable based on the allegations in a pre-suit claim which, while unsubstantiated, suggest that a reportable event may have occurred during use of atrium medicals mesh product. Claimant attributes unspecified complications to the mesh. 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.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORP.
40 continental blvd.
merrimack NH 03054
Manufacturer Contact
theresa morin
40 continental blvd.
merrimack, NH 03054
6038645237
MDR Report Key5821666
MDR Text Key132593614
Report Number1219977-2016-00161
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 foreign,other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2016
Device Model Number31533
Device Catalogue Number31533
Device Lot Number10878893
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/26/2016 Patient Sequence Number: 1
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