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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31201 - C-QUR V PATCH MEDIUM 2.5X2.5 (6.4CM)
Device Problems Material Separation (1562); Appropriate Term/Code Not Available (3191)
Patient Problems Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
Based on the review of the device history records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant.
 
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 skin irregularities, dimpling, inflammation, pain, seroma, chronic inflammatory reaction, multiple surgeries and recurrence of the hernia, incarceration, adhesions, scar tissue, drainage, bilateral component separation and panniculectomy. 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 V-PATCH
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
lori gosselin
40 continental blvd
merrimack, NH 
MDR Report Key12725044
MDR Text Key279241072
Report Number3011175548-2021-01109
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K090909
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2014
Device Model Number31201 - C-QUR V PATCH MEDIUM 2.5X2.5 (6.4CM)
Device Catalogue Number31201
Device Lot Number10812852
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/19/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/30/2021 Patient Sequence Number: 1
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