BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QUR EDGE

    MDR report key: 9558754 · Received January 7, 2020

    Report

    Report Number
    3011175548-2020-00016
    Event Type
    Injury
    Date Received
    January 7, 2020
    Report Date
    January 7, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K050311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS EVENT AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. NOT RETURNED.

    Description of Event or Problem · 1

    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 MESH THAT FAILED TO INCORPORATE, MIGRATED, INFECTION, SEVERE AND PERMANENT INJURY, PHYSICAL PAIN AND MENTAL ANGUISH. 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.

    Description of Event or Problem · 1

    PLAINTIFF ALSO ALLEGEDLY EXPERIENCED ADHESIONS, SEROSAL TEAR, ISCHEMIA, NECROSIS, DEBRIDEMENT AND LACK OF INCORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20209 C-QUR EDGE MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention