BEUDAMED
    FDA Adverse Event Other Summary report: N

    DST-XL

    MDR report key: 220398 · Received April 20, 1999

    Report

    Report Number
    9615727-1999-00008
    Event Type
    Other
    Date Received
    April 20, 1999
    Report Date
    April 19, 1999
    Manufacturer
    SMV INTL.
    Product Code
    IYX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NUCLEAR MEDICINE TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE FIBERGLASS TABLE UNDER THE DST-XL IS SPLINTERING. A PATIENT HAD TO HAVE A FIBERGLASS REMOVED FROM HIS OR HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST-XL GAMMACAMERA IYX SMV INTL. DST-XL NA

    Patients

    Seq Age Sex Outcome Treatment
    1