BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QIR TACSHIELD

    MDR report key: 11764705 · Received May 3, 2021

    Report

    Report Number
    3011175548-2021-00468
    Event Type
    Injury
    Date Received
    May 3, 2021
    Report Date
    August 2, 2021
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K100076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 REQUIREMENTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    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.

    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 MEDICALS MESH PRODUCT. PLAINTIFF ALLEGEDLY EXPERIENCED ABDOMINAL PAIN, SEROMA, AND FLUID COLLECTION. 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
    657531 C-QIR TACSHIELD MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL CORPORATION 31628 424773

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention