BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDASH

    MDR report key: 2563075 · Received April 16, 2012

    Report

    Report Number
    2311923-2012-00012
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    March 12, 2004
    Report Date
    April 16, 2012
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT DESIGN MEETS ALL FDA AND ET REQUIREMENTS FOR CONSUMER SAFETY. DEVICE HAS HANDLES FOR SUPPORT. NOT SURE WHY USER USED FAN GRILL FOR SUPPORT. FAN GRILL WAS ALTERED BY USERS OF THE DEVICE ALLOWING UNSUSPECTING CUSTOMER TO PASS FINGERS THROUGH GRILL AND REACH FAN BLADE RESULTING IN INJURY.

    Description of Event or Problem · 1

    CUSTOMER PLACED HER FINGER THROUGH FAN GRILL RESULTING IN INJURY TO FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDASH SUNDASH RADIU 252 LEJ JK PRODUCTS & SERVICES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other