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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 31237
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Edema (1820); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
We are unable to fully investigate this event as no product code, lot number, or sample was provided. Not returned.
 
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 chronic and severe adverse reactions, pain, infection, cellulitis, bowel adhesions, bowel injuries and recurrent hernias, additional surgery, physical injury, mental anguish, permanent and severe scarring. 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.
 
Event Description
Plaintiff also allegedly experienced lack of incorporation, mrsa, abscess, sinus drainage, cellulitis, edema, inflammation, wound vac and debridement.
 
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Brand NameC-QUR EDGE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8782218
MDR Text Key150752796
Report Number3011175548-2019-00747
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,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2011
Device Model Number31237
Device Catalogue Number31237
Device Lot Number10417508
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/19/2008
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: 07/11/2019 Patient Sequence Number: 1
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