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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31533
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided.
 
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 medicals mesh product. Plaintiff allegedly experienced hernia recurrence, adhesions, severe / chronic pain and discomfort. 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 CORPORATION
40 continental blvd
merrimack NH
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH
Manufacturer Contact
dorota wolpiuk
40 continental blvd
merrimack, NH 
MDR Report Key11606559
MDR Text Key243529575
Report Number3011175548-2021-00396
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
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Model Number31533
Device Catalogue Number31533
Device Lot Number215012
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/02/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/01/2021 Patient Sequence Number: 1
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