BEUDAMED
    FDA Adverse Event Summary report: N

    ERGOLINE

    MDR report key: 2988221 · Received January 31, 2013

    Report

    Report Number
    2311923-2013-00001
    Date Received
    January 31, 2013
    Date of Event
    February 1, 2012
    Report Date
    January 31, 2013
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER EXCEEDED THE WEIGHT CAPACITY OF THE DEVICE. THE ACRYLIC EXCEEDED ITS LIFE EXPECTANCY AND WAS NOT REPLACED AS IN THE INSTRUCTIONS OF THE OWNER'S MANUAL.

    Description of Event or Problem · 1

    PT WENT TO LAY ON THE TANNING BED AND BROKE THE ACRYLIC PLATFORM USED TO LAY ON. SHE RECEIVED SOME MINOR SCRATCHES IN THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42254 ERGOLINE OPEN SUN 1050 LEJ JK PRODUCTS & SERVICES 1050

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other