BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESH C-QUR

    MDR report key: 17579662 · Received August 18, 2023

    Report

    Report Number
    3011175548-2023-00163
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    UDI-DI
    00650862315363
    PMA / PMN Number
    K050311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H6 & H10 THIS REPORTED COMPLAINT INVOLVES A MESH PRODUCT, WHICH IS INVOLVED IN A LAWSUIT MADE OF GENERAL ALLEGATIONS OF ADVERSE EVENTS WITHOUT OBJECTIVE EVIDENCE OR ANY SPECIFIC DETAILS OF A PRODUCT DEFECT. THE RISK FILE ADDRESSES THE REPORTED HARM. THERE HAVE NOT BEEN ANY CONFIRMED COMPLAINTS RELATED TO A DEVICE MALFUNCTION IN REGARDS TO PAIN. AN NCR AND SCAR REVIEW IS NOT APPLICABLE. THE DEVICE WAS NOT AVAILABLE OR RETURNED FOR EVALUATION, THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE REPORTED COMPLAINT. 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. 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.

    Additional Manufacturer Narrative · 0

    UPON COMPLETION OF THE INVESTIGATION INTO THIS EVENT A FOLLOW UP REPORT WILL BE SUBMITTED. 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. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    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 WAS IMPLANTED WITH C-QUR MESH, WHICH FAILED AND EVENTUALLY DISTORTED IN SIZE AND SHAPE AND BECAME EMBEDDED IN ORGANS. PLAINTIFF ALLEGEDLY EXPERIENCED CHRONIC PAIN AND SUFFERING, DISCOMFORT, INCORPORATED MESH, EMOTIONAL DISTRESS AND LOSS OF AMENITY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330838 MESH C-QUR MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31536 10828194 00650862315363

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male UNKNOWN.