BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANOSOL 3D

    MDR report key: 12332490 · Received August 17, 2021

    Report

    Report Number
    1521608-2020-00001
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    August 5, 2020
    Report Date
    August 16, 2021
    Manufacturer
    NATIONAL BIOLOGICAL CORPORATION
    Product Code
    FTC
    PMA / PMN Number
    K872650
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS RECEIVED ON 08/05/2020. THIS REPORT IS BEING SUBMITTED AUGUST 2021. THIS REPORT WAS NOT INITIALLY SUBMITTED SINCE NATIONAL BIOLOGICAL CORP BELIEVED THE PHYSICIAN'S PRESCRIPTION OF AN ORAL ANTIBIOTIC FOR THE CUSTOMER WAS A PREVENTIVE MEASURE AND NOT AN INTERVENTION. IT WAS CLARIFIED IN AUGUST 2021 VIA EMAIL INQUIRY TO CDRH REQUESTING IF THE EVENT SHOULD BE SUBMITTED, THAT WHEN MEDICINE IS PRESCRIBED FOR AN EVENT, THE EVENT SHOULD BE REPORTED. THERE HAS BEEN NO PERMANENT OR LASTING INJURY REPORTED.

    Description of Event or Problem · 1

    THIS WAS THE FIRST USE OF PHOTOTHERAPY BY THE CUSTOMER. THE PRESCRIBED TREATMENT REGIME WAS TREATMENT EVERY OTHER DAY. AFTER THE SECOND TREATMENT, THE CUSTOMER REPORTED REDNESS AND PEELING OF HIS LEGS. ONLY HIS LEGS WERE OVERTREATED, THE REST OF THE BODY DID NOT EXPERIENCE OVERTREATMENT. FOR HIS THIRD TREATMENT, THE PHYSICIAN SUGGESTED THE CUSTOMER COVER HIS LEGS, SO THEY WERE NOT EXPOSED TO THE PHOTOTHERAPY. THE CUSTOMER HAD HIS LEGS WRAPPED AND A PHYSICIAN PRESCRIBED ORAL ANTIBIOTIC TO PREVENT THE POSSIBILITY OF AN INFECTION OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232021 PANOSOL 3D PHOTOTHERPAY UNIT FTC NATIONAL BIOLOGICAL CORPORATION UVB-631-9

    Patients

    Seq Age Sex Outcome Treatment
    1 Other