BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLDALITE III 32 LAMP

    MDR report key: 12413573 · Received September 2, 2021

    Report

    Report Number
    1521608-2021-00002
    Event Type
    Injury
    Date Received
    September 2, 2021
    Date of Event
    August 11, 2021
    Report Date
    September 2, 2021
    Manufacturer
    NATIONAL BIOLOGICAL CORPORATION
    Product Code
    FTC
    PMA / PMN Number
    K827890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NATIONAL BIOLOGICAL INVESTIGATED THE INCIDENT AND FOUND THE FOLLOWING INFORMATION. WHILE IT IS THE PHYSICIAN'S CHOICE ON THE PATIENT'S TREATMENT DOSAGES, IT WAS FOUND THAT THE PATIENT DOSAGE WAS MORE THAN DOUBLE OF THE RECOMMENDED DOSAGE LISTED IN THE IFU. THE SHELK & MORGAN PROTOCOL, REFERENCED IN OUR IFU, RECOMMENDS A SKIN TYPE OF I TO BE TREATED AT 520 MJ/CM2 AS A GOAL DOSAGE. THE PATIENT (HAS A SKIN TYPE OF I) WAS BEING TREATED AT 1375 MJ/CM2. STANDARD PROTOCOL ALSO RECOMMENDS A DOSAGE DECREASE OF AS MUCH OF 50% ONCE ERYTHEMA OCCURS, THIS DID NOT OCCUR IN THIS INSTANCE.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED OVERTREATMENT AT A CLINIC. THE PATIENT RECEIVED PHOTOTHERAPY TREATMENTS FOR > 1 YEAR AT THIS CLINIC. THE PATIENT BLISTERED AFTER ONE OF THEIR TREATMENTS AND WAS TREATED WITH PRESCRIPTION STRENGTH HYDROCORTISONE. THE TREATMENT WAS MORE THAN DOUBLE THE DOSE RECOMMENDED IN THE OPERATIONS MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316362 FOLDALITE III 32 LAMP PHOTOTHERAPY UNIT FTC NATIONAL BIOLOGICAL CORPORATION UVB-832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other