BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERGOLINE

    MDR report key: 4003508 · Received July 30, 2014

    Report

    Report Number
    2311923-2014-00006
    Event Type
    Other
    Date Received
    July 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    July 28, 2014
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER EXCEEDED THE WEIGHT CAPACITY OF THE DEVICE. THE ACRYLIC EXCEEDED IT'S LIFE EXPECTANCY.

    Description of Event or Problem · 1

    CUSTOMER ROLLED OUT OF THE TANNING BED AND BROKE THE BASE ACRYLIC INJURING THEIR SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445989 ERGOLINE PASSION LEJ JK PRODUCTS & SERVICES 34/3

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR