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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MOSAIC MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31126
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Adhesion(s) (1695); Pain (1994); Hernia (2240)
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 re-herniation, pain, adhesions, and additional revision surgery. 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 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.
 
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Brand NameC-QUR MOSAIC
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 Key9924329
MDR Text Key186514757
Report Number3011175548-2020-00502
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K121070
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number31126
Device Catalogue Number31126
Device Lot Number423309
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/22/2017
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: 04/03/2020 Patient Sequence Number: 1
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