BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-QR V-PATCH

    MDR report key: 8368797 · Received February 25, 2019

    Report

    Report Number
    3011175548-2019-00222
    Event Type
    Injury
    Date Received
    February 25, 2019
    Report Date
    February 25, 2019
    Manufacturer
    ATRIUM MEDICAL
    Product Code
    FTL
    PMA / PMN Number
    K090909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 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.

    Additional Manufacturer Narrative · 1

    WE ARE UNABLE TO FULLY INVESTIGATE THIS EVENT AS NO PRODUCT CODE, LOT NUMBER, OR SAMPLE WAS PROVIDED.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY ALSO EXPERIENCED NON-HEALING WOUND, SCAR TISSUE, ERYTHEMA, INCISION AND DRAINAGE, SEROSAL TEARS, SEROMA AND SINUS TRACT.

    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 RECURRENCE, REMOVAL SURGERY, AND PAIN. 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
    161724 C-QR V-PATCH MESH, SURGICAL, POLYMERIC FTL ATRIUM MEDICAL 31202 404236

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention