BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-SPOT

    MDR report key: 6562862 · Received May 12, 2017

    Report

    Report Number
    9021987-2017-00001
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    May 3, 2017
    Report Date
    June 14, 2017
    Manufacturer
    BEEKLEY CORPORATION
    Product Code
    JAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PARTIAL LOT OF O-SPOT (REF 652) PRODUCT WAS FOUND TO BE MIS-LABELED WITH A-SPOT (REF 651) LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344411 O-SPOT MOLE MARKERS JAC BEEKLEY CORPORATION 652 652.04251701

    Patients

    Seq Age Sex Outcome Treatment
    1