BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANOSOL 3D

    MDR report key: 5060307 · Received September 3, 2015

    Report

    Report Number
    1521608-2015-00004
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 20, 2015
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    FTC
    PMA / PMN Number
    K872651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    DURING FIRST IN HOME TREATMENT, THE PATIENT FOLLOWED HER PHYSICIAN'S RECOMMENDED TREATMENT TIME OF 10 MINUTES FRONT OF BODY AND 10 MINUTES BACK OF BODY. THE PATIENT EXPERIENCED BURNING AND BLISTERING THE DAY AFTER TREATMENT. THE PATIENT CONTACTED HER PHYSICIAN AND FOLLOWED-UP WITH AN APPOINTMENT IN WHICH THE PHYSICIAN REITERATED THE ORIGINAL RECOMMENDED TREATMENT TIME. THE PATIENT WAS PRESCRIBED A CREAM AND STEROIDS FOR THE BURNS. NBC SPOKE WITH THE PRESCRIBING PHYSICIAN WHO ADMITTED TO NOT CONSULTING THE MANUAL BUT INSTEAD USED A VERBALLY RECOMMENDED PROTOCOL FROM HIS STAFF. PHOTOTHERAPY IS NOT PERFORMED AT THE FACILITY, AND THE PHYSICIAN HAS NOT PERFORMED PHOTOTHERAPY TREATMENT IN RECENT YEARS. NBC STRONGLY BELIEVES THAT THE PATIENT EXPERIENCED AN INJURY DUE TO A LACK OF TRAINING ON THE PHYSICIAN'S AND STAFF'S PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586155 PANOSOL 3D PHOTOTHERAPY UNIT FTC NATIONAL BIOLOGICAL CORP. UVB-631 9907

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention