BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOUVA 4

    MDR report key: 4805594 · Received May 28, 2015

    Report

    Report Number
    1521608-2015-00002
    Event Type
    Injury
    Date Received
    May 28, 2015
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    KGL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DURING DISCUSSION WITH (B)(6) CLINICIANS, IT WAS FOUND THAT THE FACILITY WAS NOT FOLLOWING NBC'S RECOMMENDED / PUBLISHED PROTOCOL (KOO). THE FACILITY WAS ADVISED TO UTILIZE ONLY NBC RECOMMENDED AND PUBLISHED PROTOCOLS, AS OUTLINED IN THE IFU, FOR SAFE AND EFFECTIVE TREATMENT. THE FACILITY WAS FOLLOWING ALL OTHER NBC GUIDELINES.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344650 HOUVA 4 PHOTOTHERAPY UNIT KGL NATIONAL BIOLOGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1