BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50-13062 DEKALB VASCULAR PACK

    MDR report key: 400911 · Received June 17, 2002

    Report

    Report Number
    1034876-2002-00001
    Event Type
    Malfunction
    Date Received
    June 17, 2002
    Date of Event
    May 24, 2002
    Report Date
    June 12, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARC BETWEEN THE CAUTERY PENCIL AND A SPONGE. THE SPONGE WAS SINGED AND TOSSED TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 50-13062 DEKALB VASCULAR PACK KIT PACK KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other