BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMENIS

    MDR report key: 831547 · Received March 15, 2007

    Report

    Report Number
    2914019-2007-00105
    Event Type
    Other
    Date Received
    March 15, 2007
    Date of Event
    September 21, 2005
    Report Date
    March 15, 2007
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE LUMENIS ONE DEVICE. PER THE CUSTOMER ENGINEER CE, THE 560 NM FILTER HAD TWO SMALL BURN MARKS AND THE SUSPECT 695 FILTER WAS BADLY BURNED. THERE WERE ALSO BURN MARKS ON THE 640 NM FILTER. THE CE VERIFIED CALIBRATION OF THE LUMENIS ONE DEVICE. FILTERS WERE REPLACED BY LUMENIS AS A COURTESY. ROOT CAUSE APPEARS TO BE USE OF FILTERS WHICH HAD LOST PORTIONS OF THE COATING DUE TO THE FOREIGN MATERIAL. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER DATED JULY 25, 2006.

    Description of Event or Problem · 1

    PER THE CUSTOMER, PT REPORTED DISCOMFORT DURING IPL HAIR REMOVAL TREATMENT TO BIKINI AREA (NO PROBLEM DURING LOWER LEG TREATMENT). SUBSEQUENTLY PT REPORTED FOOTPRINTING / BLISTERS TO THIGHS AND CALVES. PT SUSTAINED SECOND DEGREE BURNS AND WAS TREATED WITH SILVADENE 1%, PT HEALING WELL PER CUSTOMER. CUSTOMER BELIEVES THAT THE FILTER LOST PART OF ITS COATING DURING THE TREATMENT SESSION DUE TO A FINGERPRINT ON THE FILTER. THE PT HAD MANY PRIOR IPL TREATMENT SESSIONS WITH VASCULIGHT ELITE, ALL AREAS WERE TREATED, EXCELLENT RESPONSE AND NEVER A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS AESTHETIC LASER GEX LUMENIS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention NONE REPORTED