BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA MEDICAL SPOT PHOTOTHERAPY LAMP

    MDR report key: 1882006 · Received October 18, 2010

    Report

    Report Number
    MW5017885
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BURTON MEDICAL PRODUCTS INC.
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WAS USING A PHOTOTHERAPY LAMP MFG BY BURTON MEDICAL. THE CUSTOMER HAD REPLACED THE BULB IN THE UNIT WITH A BULB THAT DID NOT MEET THE MFR'S SPECIFICATIONS. THE CUSTOMER REPORTED THAT SUBSEQUENT USE OF THE LAMP "BURNED THE BABIES' SKIN." THE AVAILABLE INFO DOES NOT INDICATE THAT THERE WAS ANY SERIOUS INJURY OR ANY EMERGENT CARE. DOSE OR AMOUNT: NA; FREQUENCY: NA. DIAGNOSIS OR REASON FOR USE: UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA MEDICAL SPOT PHOTOTHERAPY LAMP PHOTOTHERAPY LAMP LBI BURTON MEDICAL PRODUCTS INC. P/T LT FLOOR 120V UNK

    Patients

    Seq Age Sex Outcome Treatment
    1