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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR TACSHIELD MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31610
Device Problem Material Twisted/Bent (2981)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); 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 severe pain, discomfort and tenderness, recurrence, adhesions, seroma, infection, bowel obstruction, additional surgery, bunched mesh, mental anguish, severe emotional distress, permanent and severe scarring and disfigurement. 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
Based on the review of the device history and sterilization records and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirements.
 
Event Description
Plaintiff also allegedly experienced incarceration and purulent drainage.
 
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Brand NameC-QUR TACSHIELD
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 Key9566068
MDR Text Key174268849
Report Number3011175548-2020-00028
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K100076
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 01/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model Number31610
Device Catalogue Number31610
Device Lot Number401501
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/29/2015
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: 01/08/2020 Patient Sequence Number: 1
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