BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOUVA-LIFE COMBINATION UNIT

    MDR report key: 28914 · Received December 20, 1995

    Report

    Report Number
    MW1007968
    Event Type
    Injury
    Date Received
    December 20, 1995
    Date of Event
    October 2, 1995
    Report Date
    December 8, 1995
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    KGL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TIMER ON UNIT MALFUNCTIONED AND DID NOT SHUT OFF AT THE SPECIFIED TIME. PT RECEIVED FIRST AND SECOND DEGREE BURNS AND PHOTO RADIATION INDUCED CELLULITIS. PT WAS ADMITTED TO HOSP BURN UNIT. MFR WAS NOTIFIED AND REPAIRMAN CONFIRMED TIMER WAS MALFUNCTIONING ON 10/23/95. TIMER WAS REPLACED ON 10/30/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOUVA-LIFE COMBINATION UNIT PHOTOTHERAPY UNIT KGL NATIONAL BIOLOGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization