BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALOMAR MEDILUX

    MDR report key: 557966 · Received October 5, 2004

    Report

    Report Number
    MW1033394
    Event Type
    Injury
    Date Received
    October 5, 2004
    Date of Event
    January 10, 2004
    Report Date
    October 4, 2004
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES
    Product Code
    FSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTING IN 2004 TO PRESENT, FACILITY HAS HAD -IPL- INTENSED PULSED LIGHT TREATMENTS FOR HAIR REMOVAL IN A SMALL AREA ON THE FACE. THEY NOW HAVE A LARGE AREA COVERING THE FACE WITH A HIGH VOLUME OF UNWANTED HAIR GROWTH THAT WAS NOT THERE PRIOR TO TREATMENTS. CALLED THE COMPANY & THEY SAID THIS HAS BEEN KNOWN TO HAPPEN. THE HEAT FROM THE IPL TRIGGERS SOMETHING IN THE LYMPHATIC SYSTEM & CAN CREATE MORE HAIR GROWTH, BUT THEY DID NOT HAVE TO DISCLOSE THIS TO PATIENTS BECAUSE IT DOES NOT ALWAYS HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALOMAR MEDILUX INTENSED PULSED LIGHT FSQ PALOMAR MEDICAL TECHNOLOGIES MEDILUX *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention