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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR EDGE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31236
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Adhesion(s) (1695); Pain (1994); Scarring (2061); 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. Attorney.

 
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¿s mesh product. Plaintiff allegedly experienced on ((b)(6) 2010) recurrent incisional hernia, seroma, chronic abdominal pain, on ((b)(6) 2010) abdominal pain, abdominal fluid collection and on ((b)(6) 2012) incisional hernia, adhesions to small bowel, omentum, and colon to 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 EDGE
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
40 continental blvd
merrimack, NH 
MDR Report Key11009014
MDR Text Key221479160
Report Number3011175548-2020-01437
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2009
Device MODEL Number31236
Device Catalogue Number31236
Device LOT Number10178201
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/05/2007
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: 12/15/2020 Patient Sequence Number: 1
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