BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNDASH

    MDR report key: 3173419 · Received April 29, 2013

    Report

    Report Number
    2311923-2013-00002
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 29, 2013
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION OF THIS UNIT WAS STOPPED IN 2001. THIS IS THE ONLY KNOWN INCIDENT OF THIS KIND. WE HAVE PROVIDED SALON OWNER LABELING TO PLACE ON UNIT TO AVOID FUTURE OCCURRENCES.

    Description of Event or Problem · 1

    COMPLAINANT CLOSED THE DOOR OF THE TANNING UNIT ON HER FOOT WHILE ENTERING THE UNIT. SHE RECEIVED 5 STITCHES ON HER HEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186428 SUNDASH RADIUS 48 LEJ JK PRODUCTS & SERVICES, INC. SR48

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention