BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMES

    MDR report key: 3023352 · Received March 1, 2013

    Report

    Report Number
    3003862163-2013-00014
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS SENT A PREPAID LABEL TO RETURN THE PRODUCT FOR EVALUATION, BUT THE CONSUMER HAS NOT RETURNED THE RPODUCT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES A HUMIDIFIER MELTED AND BURNED A HOLE THROUGH THE BODY OF THE UNIT. NO INJURIES OR PROPERTY DAMAGES WERE REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90509 HOLMES HUMIDIFIER KFZ JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS HM495-UC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1