BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERAFORM ADAPTABLE TISSUE MARKER

    MDR report key: 20810926 · Received November 27, 2024

    Report

    Report Number
    MW5162964
    Event Type
    Other
    Date Received
    November 27, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 21, 2024
    Manufacturer
    VISCUS BIOLOGICS, LLC.
    Product Code
    IYE
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PRODUCT CALLED VERAFORM WAS IMPLANTED. THIS PRODUCT WAS PLACED IN THE BREAST WHICH REMAINS IN THE PATIENT FOR FUTURE IMAGING. THERE WAS SOME CONCERN REGARDING THE PRODUCT'S EXPIRATION DATE AFTER THE PRODUCT WAS USED. AFTER THE DATE WAS QUESTIONED, IT WAS BROUGHT TO MANAGEMENT'S ATTENTION. THE COMPANY WAS CONTACTED TO CLARIFY HOW THE EXPIRATION DATE SHOULD BE INTERPRETED, AND IT WAS DETERMINED AT THIS TIME THAT THE PRODUCT WAS EXPIRED. THE MANUFACTURER WAS CALLED TO CLARIFY THE EXPIRATION DATE, AS IT WAS A CONCERN HOW IT WAS WRITTEN. A REPRESENTATIVE OF THE VERAFORM COMPANY ALSO MISREAD AND SAID THE PRODUCT WAS NOT EXPIRED. THE CEO OF THE COMPANY SENT DATA SHOWING THE STABILITY OF THE PRODUCT WOULD NOT EXPIRE UNTIL JANUARY 9, 2025 FOR LOT 05-2108-001. SURGEON WAS MADE AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303608 VERAFORM ADAPTABLE TISSUE MARKER ACCELERATOR, LINEAR, MEDICAL IYE VISCUS BIOLOGICS, LLC. (10) 05-2108-001

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female