BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUNDASH

    MDR report key: 2574845 · Received May 11, 2012

    Report

    Report Number
    2311923-2012-00018
    Event Type
    Death
    Date Received
    May 11, 2012
    Date of Event
    May 6, 2012
    Report Date
    May 10, 2012
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT DEATH OCCURRED IN THE SAME ROOM THE DEVICE WAS LOCATED IN. CAUSE OF DEATH HAS NOT BEEN DETERMINED YET AND MDR IS BEING SUBMITTED PRECAUTIONARY REASONS, AND FOR COMPLIANCE WITH THE FDA EVEN THOUGH IT HAS NOT BEEN CONFIRMED IF THE DEVICE CAUSED OR CONTRIBUTED TO DEATH. THE DEVICE WAS INSPECTED BY (B)(4) (JK PRODUCTS REP), (B)(4), AND (B)(6) MEDICAL EXAMINERS AND NO HAZARDOUS ISSUES WERE FOUND.

    Description of Event or Problem · 1

    PT WAS FOUND DECEASED IN THE SAME ROOM AS DEVICE, BUT OUTSIDE OF DEVICE BY SALON ATTENDANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death