BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS LUMEA COMFORT

    MDR report key: 5649992 · Received May 12, 2016

    Report

    Report Number
    3009226815-2016-00001
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    January 1, 2016
    Report Date
    February 2, 2016
    Manufacturer
    PHILIPS CONSUMER LIFESTYLE
    Product Code
    GEX
    PMA / PMN Number
    K082298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST TIME WE HAVE RECEIVED THIS TYPE OF COMPLAINT. THE UNIT HAS BEEN REQUESTED FROM THE CONSUMER FOR FURTHER EVALUATION. (2016). PLEASE NOTE THAT THE PROBLEM CODES WERE MATCHED AS BEST AS POSSIBLE FROM THE ORGINAL REPORT SUBMITTED IN 2016 BASED ON THE DESCRIPTION OF THE EVENT BY THE CONSUMER.

    Description of Event or Problem · 0

    THE CONSUMER CLAIMS THAT DURING THE FIRST USE THE DEVICE WAS WORKING AS EXPECTED. AFTER SOME PULSES, THE DEVICE FLASHED IN A MORE INTENSE WAY THAN NORMAL. THE CONSUMER RECEIVED CRAMPS AND REFERENCED THE MORE INTENSE LIGHT AS 'SPARKS'. THE CONSUMER CLAIMS THAT THE UNIT KEPT ON SHUTTING OFF AFTER THAT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608061 PHILIPS LUMEA COMFORT IPL GEX GEX PHILIPS CONSUMER LIFESTYLE SC1983/00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female