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U.S. Department of Health and Human Services

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

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ATRIUM MEDICAL CORPORATION C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 31544
Device Problems Material Protrusion/Extrusion (2979); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
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. This report is based upon allegations made in a lawsuit in which atrium medical is named as a defendant. This report shall not be considered as an admission by atrium medical that the product described in the lawsuit claim and described herein is or was defective, or that it had any causal relationship to any injuries allegedly suffered by the plaintiff.

 
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 hernia recurrence, abdominal pain, adhesions, mesh extrusion, mesh contracture/shrinkage, wadded up mesh, migration, lack of incorporation, 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 NameC-QUR MESH
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 Key10267450
MDR Text Key198628404
Report Number3011175548-2020-00900
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,Followup
Report Date 07/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/29/2017
Device MODEL Number31544
Device Catalogue Number31544
Device LOT Number201306
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/14/2014
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: 07/13/2020 Patient Sequence Number: 1
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