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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION MESH C-QUR MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31528
Device Problem Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

Based on the review of the device history and product complaint details atrium can find no fault with the product. This lot of mesh passed all quality and performance requirement. Product 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 contracture of mesh, adhesions, lysis of adhesions, recurrent incisional hernia, and additional 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.

 
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Brand NameMESH C-QUR
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 Key10452263
MDR Text Key204333529
Report Number3011175548-2020-01061
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
Report Date 08/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2015
Device MODEL Number31528
Device Catalogue Number31528
Device LOT Number10841988
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/02/2012
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: 08/25/2020 Patient Sequence Number: 1
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