BEUDAMED
    FDA Adverse Event Summary report: N

    CORRECT PLUS IMPRESSION MATERIAL

    MDR report key: 7731110 · Received July 27, 2018

    Report

    Report Number
    MW5078670
    Date Received
    July 27, 2018
    Date of Event
    July 23, 2018
    Report Date
    July 24, 2018
    Manufacturer
    PENTRON / KERR CORPORATION
    Product Code
    ELW
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DENTAL PUTTY WAS BEING USED TO CREATE A CUSTOM BITE BLOCK FOR RAD ONCOLOGY SIMULATION TREATMENT. AFTER SEVERAL ATTEMPTS WERE MADE TO REMOVE THE BITE BLOCK, IT CAME LOOSE, BUT ALSO REMOVED THREE OF THE PATIENT'S DENTAL CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568470 CORRECT PLUS IMPRESSION MATERIAL IMPRESSION MATERIAL ELW PENTRON / KERR CORPORATION 6270440

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR