BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM HR

    MDR report key: 633487 · Received September 6, 2005

    Report

    Report Number
    2914019-2005-00043
    Event Type
    Injury
    Date Received
    September 6, 2005
    Date of Event
    July 12, 2005
    Report Date
    September 6, 2005
    Manufacturer
    LUMENIS (ISREAL)
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    QUANTUM OWNER OR USER CONTACTED LUMENIS CLINICAL EDUCATION AND REPORTED A PT WHO RETURNED FOR EVALUATION AFTER THE SIXTH QUANTUM HR HAIR REMOVAL TREATMENT TO THE AXILA, CLAIMING TO HAVE DEVELOPED A RAISED SCAR WHICH ACCORDING TO THE PT IS A KELOID SCAR. PER THE LUMENIS CLINICAL EDUCATOR, THE AESTHETICIAN INCREASED THE INFLUENCE TOO AGGRESIVELY (WENT FROM 34 J TO 37 J ON SHORT PULSE ON THE SIXTH TREATMENT) (USER ERROR). THE QUANTUM HR OPERATOR MANUAL STATES THAT THERE IS A VERY SMALL CHANCE OF SCARRING, SUCH AS ENLARGED HYPERTROPHIC SCARS, WITH THE QUANTUM HR. THE QUANTUM HR OPERATOR MANUAL ALSO STATES THAT IN VERY RARE CASES, ABNORMAL, LARGE, RAISED KELOID SCARS MAY APPEAR AND THAT TP REDUCE THE CHANCE OF SCARRING, IT IS IMPORTANT TO CAREFULLY FOLLOW ALL POST-TREATMENT INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM HR QUANTUM GEX LUMENIS (ISREAL) QUANTUM HR *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other