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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 31240
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060)
Event Type  Injury  
Manufacturer Narrative

We are unable to fully investigate this event as no product code, lot number, or sample was provided. Device evaluated by manufacturer? 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 infection, open draining wound, necrosis, sinus tract, additional surgery, adhesions, inflammation, foreign body giant cell reaction, skin with superficial ulcer, abscess, chronic abdominal pain, hernia recurrence, abdominal wall reconstruction, scarring, and ischemia to the umbilicus. 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 Key11059894
MDR Text Key223359202
Report Number3011175548-2020-01492
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 12/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2009
Device MODEL Number31240
Device Catalogue Number31240
Device LOT Number10199601
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/15/2007
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: 12/22/2020 Patient Sequence Number: 1
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