BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QR V-PATCH

    MDR report key: 10184995 · Received June 23, 2020

    Report

    Report Number
    3011175548-2020-00853
    Event Type
    Injury
    Date Received
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE REVIEW OF THE MEDICAL RECORDS THIS MESH WAS NOT AN IMPLANTED DEVICE.

    Description of Event or Problem · 0

    BASED ON THE REVIEW OF THE MEDICAL RECORDS THIS MESH WAS NOT AN IMPLANTED DEVICE.

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS EVENT AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED. DEVICE EVALUATED BY MANUFACTURER? 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 ADDITIONAL SURGERY, INFECTION, OPEN DRAINING WOUND, AND SEROMA. 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
    647000 C-QR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention