BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUANTUM

    MDR report key: 1236812 · Received October 30, 2008

    Report

    Report Number
    2914019-2008-00057
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 27, 2008
    Report Date
    October 28, 2008
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K020839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL BY THE FIELD SVC ENGINEER OF THE SYSTEM FOUND THERE WAS GEL BUILT UP ON THE HEAD, AND THE POWER METER WAS DIRTY IN CONTRADICTION TO CLEANING GUIDELINES PER PRODUCT LABELING. ADDITIONALLY, IT WAS REPORTED THAT THE PT WAS PRESCRIBED DYNACIN PRIOR TO TREATMENT. PHOTO SENSITIVE MEDICATIONS ARE LISTED AS A CONTRA-INDICATION PER PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUSTAINED BURNING AS THE RESULT OF AN IPL TREATMENT. A FULL RECOVERY WAS REPORTED BY THE USER FACILITY. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM IPL QUANTUM GEX LUMENIS, LTD. GA3500000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other