BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOUVA II

    MDR report key: 3697253 · Received January 8, 2014

    Report

    Report Number
    1521608-2013-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 11, 2013
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THESE DEVICES WERE DISTRIBUTED IN ACCORDANCE WITH THEIR CURRENT PERFORMANCE SPECIFICATIONS. NBC WAS SCHEDULED AN EVAL AND REPAIR OF THESE PHOTOTHERAPY DEVICES. THE INTENTION IS TO BRING UNITS UP TO THE ORIGINAL SPECIFICATION WHICH THESE WERE DISTRIBUTED. ALSO NBC WILL TRAIN AND COUNSEL THE CUSTOMER ON USING AND MAINTAINING THE DEVICES WITHIN THEIR LABELED INDICATIONS.

    Description of Event or Problem · 1

    NATIONAL BIOLOGICAL CORPORATION (NBC) BECAME AWARE THAT A CUSTOMER (PHYSICIAN'S OFFICE) IS USING TWO NBC PHOTOTHERAPY DEVICES (HOUVA II) WHICH THEY HAVE ADULTERATED. THEREFORE, THE UNITS ARE NO LONGER CONFIGURED IN ACCORDANCE WITH NBC SPECIFICATIONS AND ARE NOT BEING USED IN ACCORDANCE WITH NBC LABELED INDICATIONS FOR USE AS WHEN THESE DEVICES WERE INITIALLY DISTRIBUTED. BOTH HOUVA II PHOTOTHERAPY DEVICES' LAMPS HAD BEEN REPLACED WITH INCOMPATIBLE NON-MEDICAL GRADE LAMPS. SUBSEQUENTLY THE CUSTOMER DID INDICATE THAT A PT HAD RECEIVED A BURN USING ONE OF THE ADULTERATED DEVICES. NATIONAL BIOLOGICAL CORPORATION RECORDS INDICATE THAT ONE HOUVA II PHOTOTHERAPY DEVICE, S/N (B)(4) WAS SOLD DIRECTLY TO THIS LOCATION AND PHYSICIAN. THE OTHER HOUVA II PHOTOTHERAPY DEVICE, S/N (B)(4) WAS NOT SOLD DIRECTLY BY NBC TO THIS LOCATION AND PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13592 HOUVA II PHOTOTHERAPY UNIT LBI NATIONAL BIOLOGICAL CORP. UAB-001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other