BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENISONE

    MDR report key: 828044 · Received March 13, 2007

    Report

    Report Number
    2914019-2005-00076
    Event Type
    Injury
    Date Received
    March 13, 2007
    Date of Event
    July 22, 2005
    Report Date
    March 13, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS SERVICE EVALUATED THE LUMENIS ONE DEVICE. PER THE CUSTOMER ENGINEER CE, THE TREATMENT HEAD WAS DEFECTIVE. LUMENIS REPLACED THE TREATMENT HEAD ALONG WITH THE LIGHT GUIDE (EXPERT FILTER) AND THE DEFECTIVE HEAD WAS SENT TO THE MANUFACTURING SITE FOR EVALUATION. EVALUATION OF THE TREATMENT HEAD WAS NOT POSSIBLE AS THE SHIPMENT WAS APPARENTLY LOST IN TRANSIT. THIS TREATMENT HEAD WAS INSTALLED TOGETHER WITH THE LUMENIS ONE DEVICE ON 4/27/2005. LUMENIS WARRANTS THE LUMENIS ONE UNIVERSAL IPL HEAD TO 30,000 PULSES OR ONE YEAR (WHICH EVER OCCURS FIRST). RESULTS AND CONCLUSION: INVESTIGATION OF THE INJURY WAS LIMITED BY LATE REPORTING OF THE INJURY TO THE PHYSICIAN AND TO LUMENIS. IT IS POSSIBLE THAT THE FAILURE OF THE IPL TREATMENT HEAD CONTRIBUTED DIRECTLY OR INDIRECTLY TO THE PATIENT INJURY. HOWEVER, WITHOUT ADDITIONAL PATIENT AND INCIDENT DETAILS FROM THE CUSTOMER, NO FURTHER CONCLUSION CAN BE DRAWN. 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 PHYSICIAN, THE LASER SOUNDED LIKE A FIRECRACKER FROM THE UNIVERSAL IPL TREATMENT HEAD, AND IT WAS SMOKING AND HAS A LARGE BURN MARK ON THE FILTER. ONE PATIENT REPORTED BLISTERS TO THE CHEST, BUT DID NOT REPORT THE PROBLEM UNTIL A FOLLOW-UP VISIT (THEREFORE, MEDICAL INTERVENTION HAD NOT BEEN A CONSIDERATION).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED