BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRACE CART W/LID-24"-6/CS

    MDR report key: 382143 · Received March 7, 2002

    Report

    Report Number
    1057373-2002-00008
    Event Type
    Other
    Date Received
    March 7, 2002
    Date of Event
    February 5, 2002
    Report Date
    February 7, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEAM ON BOTTOM IS NOT SEALED. ITEM WAS USED IN SURGERY AND CANNOT BE RETURNED DUE TO BIOHAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRACE CART W/LID-24"-6/CS SCM STANDARD TRACECART EMPTIES KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other