BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOUVA II PHOTOTHERAPY SYSTEM

    MDR report key: 525150 · Received May 11, 2004

    Report

    Report Number
    1521608-2004-00001
    Event Type
    Injury
    Date Received
    May 11, 2004
    Date of Event
    April 12, 2004
    Report Date
    May 11, 2004
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    KGL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A PT HAD AN ERYTHEMAL RESPONSE TO AN ULTRAVIOLET A (PUVA) TREATMENT. PUVA TREATMENTS CONSIST OF UVA LIGHT TREATMENTS IN CONJUNCTION WITH A PHOTOSENSITIZING AGENT. IT WAS REPORTED THAT THE PT HAD TAKEN ADDITIONAL MEDICATION THAT CONTAINED PHOTOSENSITIZING AGENTS. IT WAS ALSO NOTED THAT PT MAY HAVE DOUBLED THEIR DOSE OF ONE OF THESE. THE RESPONSE OCCURRED 24-48 HOURS AFTER TREATMENT. THE PT WAS HOSPITALIZED FOR TWO DAYS AND REPORTED TO ALSO UNDERGO SOME FOLLOW-UP TREATMENTS. THERE WAS NO MISUSE OR MALFUNCTION OF THE DEVICE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUVA II PHOTOTHERAPY SYSTEM ULTRAVIOLET LIGHT CABINET KGL NATIONAL BIOLOGICAL CORP. UAB-102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization UNK - IDENTITY OF MEDS TAKEN ORALLY IS UNK.