BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 3330562 · Received September 6, 2013

    Report

    Report Number
    3004135191-2013-00060
    Event Type
    Injury
    Date Received
    September 6, 2013
    Report Date
    September 6, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K060448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT CONTACTING THE USER FACILITY TO REQUEST DETAILS OF THE PATIENT'S REPORT, PATIENT TREATMENT RECORDS AND PATIENT PHOTOGRAPHS. DURING A TELEPHONE CALL WITH THE TREATING PHYSICIAN LUMENIS WAS INFORMED THAT THE PATIENT DID NOT SUPPLY EVIDENTIARY DOCUMENTATION TO SUPPORT THE PATIENT'S CLAIMS. THE FACILITY HAS NOT RELEASED THE PATIENT'S RECORD, PHOTOGRAPHS OR ANY OTHER INFORMATION REGARDING THE REPORTED EVENT TO LUMENIS. A REVIEW OF SUBJECT DEVICE SERVICE RECORDS FOUND THAT THE SUBJECT DEVICE HAD BEEN REGULARLY SERVICED AND MAINTAINED BY QUALIFIED LUMENIS TECHNICIAN. THE SUBJECT DEVICE MET ALL MANUFACTURER SPECIFICATIONS. SUBJECT DEVICE MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE REPORTED EVENT. ABSENT PATIENT TREATMENT RECORDS OR OTHER EVIDENCE LUMENIS IS UNABLE TO SUBSTANTIATE THE PATIENT'S CLAIMS OR TO DETERMINE A ROOT CAUSE. SHOULD RELEVANT INFORMATION BE PROVIDED TO LUMENIS REGARDING THIS REPORT, LUMENIS WILL FILE A FOLLOW-UP MEDWATCH REPORT. INCIDENT OCCURRED APPROX. FOUR YEARS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED SKIN CANCER FOUR YEARS POST IPL TREATMENT WITH A LUMENIS ONE LASER. IT WAS FURTHER REPORTED BY THE PATIENT TO THE TREATING FACILITY THAT THE CANCER OCCURRED ON AN AREA TREATED WITH THE SUBJECT DEVICE. THE PATIENT REPORTEDLY WAS TREATED BY A DERMATOLOGIST NOT ASSOCIATED WITH THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442544 LUMENIS ONE INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. LUMENIS ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other