BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS LUMEA COMFORT

    MDR report key: 5634002 · Received May 5, 2016

    Report

    Report Number
    3009226815-2016-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 25, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
    Product Code
    OHT
    PMA / PMN Number
    K141242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST TIME THIS TYPE OF COMPLAINT HAS BEEN RECEIVED. IT IS NOT KNOWN IF THE CONSUMER HAD A PRE-EXISTING CONDITION THAT WOULD HAVE CAUSED THE DIAGNOSIS. THE UNIT HAS BEEN REQUESTED BACK FROM THE CONSUMER FOR INVESTIGATION AND ANALYSIS. WITHOUT AN INVESTIGATION OF THE ACTUAL UNIT, WE ARE UNABLE TO CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    CONSUMER CLAIMS THAT WHEN USING THE DEVICE OVER HER CALF SHE PRESSED THE BUTTON FOR A FLASH, BUT THE FLASH DID NOT COME ON INSTANTLY. SHE HAD TIME TO PULL THE DEVICE AND JUST AT THAT TIME THE FLASH OCCURRED. SHE WAS LOOKING DIRECTLY INTO THE LIGHT AND SAW WHITE MARKS IN HER SIGHT FOR A FEW HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288700 PHILIPS LUMEA COMFORT IPL GEX OHT PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV SC1981/00

    Patients

    Seq Age Sex Outcome Treatment
    1