BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REXYLLIUM 5

    MDR report key: 278786 · Received May 19, 2000

    Report

    Report Number
    MW1018948
    Event Type
    Injury
    Date Received
    May 19, 2000
    Date of Event
    February 1, 2000
    Report Date
    May 19, 2000
    Manufacturer
    JENERIC/PENTRON, INC.
    Product Code
    EJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR HAS BEEN DIAGNOSED WITH POLYCYTHEMIA VERA AND IS QUESTIONING WHETHER THIS CONDITION MAY HAVE BEEN CAUSED BY REPEATED EXPOSURE TO BERYLLIUM PARTICULATES IN THE AIR OVER THE PAST 30 YEARS. THE RPTR IS VERY ACTIVE IN THE DENTAL ASSOCIATION AND IS MAINLY CONCERNED THAT THERE MAY BE A SAFER ALLOY AVAILABLE. THE RPTR FINDS NO FAULT WITH THE MFR, BUT FEELS MORE STUDIES ARE NEEDED ON THE POSSIBILITY OF CONTRACTING BERYLLIOSIS FROM THIS TYPE OF EXPOSURE TO BERYLLIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REXYLLIUM 5 DENTAL ALLOY WITH 2% BERYLLIUM EJT JENERIC/PENTRON, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR