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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL C-QUR V-PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31201
Device Problem Extrusion (2934)
Patient Problems Adhesion(s) (1695); 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.
 
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 recurrence surgery, pain, adhesion, and extrusion. 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.
 
Manufacturer Narrative
Investigation: 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 requirement.
 
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Brand NameC-QUR V-PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7280338
MDR Text Key100402533
Report Number3011175548-2018-00159
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,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2012
Device Model Number31201
Device Catalogue Number31201
Device Lot Number10551928
Other Device ID Number00650862312010
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/18/2009
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: 02/19/2018 Patient Sequence Number: 1
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