BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTODERM VL MACHINE

    MDR report key: 249828 · Received November 16, 1999

    Report

    Report Number
    MW1017560
    Event Type
    Injury
    Date Received
    November 16, 1999
    Date of Event
    June 1, 1999
    Report Date
    November 16, 1999
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS SEEN FOR VARICOSE OR "SPIDER VEIN" REMOVAL WITH A "LASER TYPE" DEVICE ON HER LEGS. PT NOW HAS PERMANENT HYPOPIGMENTATION IN STRIPES DOWN HER LEGS. ACCORDING TO REPORTER THE SALESPERSON AT THE MFR SAID THIS COULD ONLY HAVE OCCURRED DUE TO USER ERROR. ALSO ACCORDING TO THE PT THE DR PRESCRIBED EMLA CREAM FOR USE PRIOR TO THE TREATMENT, BUT THAT THE PHYSICIAN DENIES ANY LIABILITY BECAUSE THE TREATMENTS ARE PERFORMED AND THE LASER OWNED BY AN LPN, TO WHOM HE RENTS OFFICE SPACE. THE REPORTER HAS REPORTED BOTH THE NURSE AND THE PHYSICIAN TO THEIR RESPECTIVE BOARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTODERM VL MACHINE "LASER TYPE" DEVICE GEX ESC MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR