BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERGOLINE

    MDR report key: 4808790 · Received May 28, 2015

    Report

    Report Number
    2311923-2015-00001
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    April 24, 2015
    Report Date
    April 29, 2015
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    LEJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TANNING APPLIANCE MODEL HAS BEEN TESTED WHERE APPLICABLE AND FOUND TO BE IN COMPLIANCE WITH UNDERWRITERS LABORATORY STANDARDS UL (B)(4) LUMINARIES, UL (B)(4) PORTABLE SUN/HEAT LAMPS, AND UL (B)(4) COMMERCIAL REFRIGERATORS AND FREEZERS. THIS TESTING RESULTED IN THE LISTING AND APPROVAL TO BE MARKED WITH THE INTERTEK TESTING SERVICES (ETL) CERTIFICATION (REPORT NUMBER (B)(4)). THIS INCIDENT HAS BEEN INVESTIGATED TO THE FULLEST EXTENT POSSIBLE GIVEN THE INFORMATION PROVIDED AND ONLY LIMITED ACCESS TO SAID TANNING APPLIANCE BY THE SALON, DUE TO THE ANTICIPATION OF A LIABILITY CLAIM BEING FILED BY THE INJURED CUSTOMER. OUR FINDINGS SHOW THAT AS PRODUCED THE FAN GRILL PROVIDES PROPER PROTECTION FROM INADVERTENT CONTACT WITH THE FAN. THE LACK OF EVIDENCE I.E. BLOOD AND INABILITY TO LOCATE THE MISSING APPENDAGES, RAISES QUESTION AS TO THE EXACT ACCOUNT OF HOW THE INCIDENT OCCURRED. OUR INVESTIGATION CONCLUDES THAT GIVEN THE STANDARDS USED TO TEST AND EVALUATE OUR PRODUCT, PLUS THE SMALL OPENINGS OF THE FAN GRILL AND PROXIMITY OF THE FAN BLADES TO THE GRILL, COMBINED WITH THE FACT THAT THE FAN IS LOCATED AT THE FOOT END OF THE BED AND BEING THE FURTHEST MOST POINT FROM THE USER CONTROLS INCLUDING THE START/STOP BUTTON. THEREFORE WE ARE CONFIDENT THE INCIDENT WAS NOT CAUSED BY THE DEVICE, AND CONCLUDE THE INCIDENT WAS A RESULT OF IMPROPER USE AND/OR MODIFICATION OF THE FAN FROM ITS AS PRODUCED STATE.

    Description of Event or Problem · 1

    INJURY TO FINGERS WHEN THEY WERE ALLEGEDLY INSERTED INTO THE FOOT FAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346154 ERGOLINE SUNTAN BED LEJ JK PRODUCTS & SERVICES AMBITION 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other