BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XTRAC EXCIMER AL10000

    MDR report key: 3299647 · Received August 15, 2013

    Report

    Report Number
    2031934-2013-00001
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    May 22, 2013
    Report Date
    August 14, 2013
    Manufacturer
    PHOTO MEDEX, INC.
    Product Code
    GEX
    PMA / PMN Number
    K073659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BURNING IS A NORMAL OUTCOME OF TREATMENT WITH UVB THERAPY, AND IS ACTUALLY INDICATIVE OF SUCCESSFUL TREATMENT. HOWEVER, BURNS CAUSING OPEN WOUNDS ARE NOT CONSIDERED NORMAL. A COMPANY REPRESENTATIVE FOLLOWED-UP WITH THE PATIENT, AND CONFIRMED THE INITIAL REPORTED INFORMATION AND CONFIRMED THAT THE PATIENT HAD HEALED FROM HER BURNS. A COMPANY REPRESENTATIVE ALSO SPOKE TO THE TREATING FACILITY AND CONFIRMED THE DEVICE IN QUESTION AND THE TREATMENT PARAMETERS. THE TREATMENT PARAMETERS WERE NORMAL PER THE TREATMENT PROTOCOL. ADDITIONALLY, A FIELD SERVICE REPRESENTATIVE EVALUATED THE DEVICE AT THE TREATING FACILITY, AND DETERMINED IT WAS OPERATING WITHIN SPECIFICATION. WE DO NOT BELIEVE THE DEVICE MALFUNCTIONED TO CAUSE THIS ADVERSE REACTION; IT REMAINS UNCLEAR WHY THE PATIENT BURNED SEVERELY ENOUGH TO REQUIRE MEDICAL TREATMENT. AS STATED ABOVE, BURNING IS NORMAL AN ALL PATIENTS REACT DIFFERENTLY TO UVB EXPOSURE. UPON INITIAL REVIEW OF THE COMPLAINTS DETAILS, IT DID NOT APPEAR TO BE A REPORTABLE INCIDENT. AFTER FURTHER REVIEW AND DISCUSSION, PHOTOMEDEX LATER DETERMINED IT WAS NECESSARY TO REPORT THIS INCIDENT. THIS EXPLAINS THE TIME LAG IN REPORTING.

    Description of Event or Problem · 1

    PATIENT TREATED WITH DEVICE, DEVELOPED BURNS ON THE BOTTOM OF HER FEET. PATIENT SOUGHT MEDICAL ATTENTION AT AN ED, BURNS ASSESSED TO BE 2ND DEGREE AND TREATED WITH PROPHYLACTIC ANTIBIOTICS AND SILVADENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393532 XTRAC EXCIMER AL10000 EXCIMER LASER SYSTEM GEX PHOTO MEDEX, INC. AL10000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention