BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 315082 · Received February 6, 2001

    Report

    Report Number
    MW1021013
    Event Type
    Other
    Date Received
    February 6, 2001
    Date of Event
    January 17, 2001
    Report Date
    February 5, 2001
    Manufacturer
    ILLE DIV. OF MARKET FORGE (FERNO WASHINGTON, INC.)
    Product Code
    IMC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS INSTRUCTED TO PLACE HAND IN PARAFTIN BATH BY THERAPIST. PT C/O BATH BEING "HOT". WHEN THERAPIST CHECKED TEMP IT WAS 155 DEGREES. PT RECEIVED 1ST DEGREE BURN TO FINGERS. THERAPIST FOUND SWITCH HAD BEEN CHANGED TO "START" INSTEAD OF "OPERATE". NO INFO ON DEVICE RE: SAFE/THERAPEUTIC TEMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4380 * PARAFTIN CONSTANT TEMP BATH IMC ILLE DIV. OF MARKET FORGE (FERNO WASHINGTON, INC.) 112 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other