BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-2

    MDR report key: 617984 · Received June 3, 2005

    Report

    Report Number
    617984
    Event Type
    Malfunction
    Date Received
    June 3, 2005
    Date of Event
    May 5, 2005
    Report Date
    June 3, 2005
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    IRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BROKEN THERMOSTAT IN HYDROCOLLATOR UNIT CAUSING TEMPERATURE TO RISE ABOVE THE RECOMMENDED OPERATING RANGE RESULTING IN FIRST DEGREE BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-2 HYDROCOLLATOR IRQ CHATTANOOGA GROUP, INC. 2402-2403-2404 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR