BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 406615 · Received July 16, 2002

    Report

    Report Number
    MW1025622
    Event Type
    Other
    Date Received
    July 16, 2002
    Date of Event
    July 9, 2002
    Report Date
    July 15, 2002
    Manufacturer
    OLYMPIC MEDICAL CORP
    Product Code
    LBI
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT IN CRIB W/PHOTOTHERAPY LIGHT IN PLACE. PLEXIGLASS COVERING LIGHT BULBS FELL OUT INTO CRIB. RED MARKS NOTED ON INFANT'S LEFT THIGH AND LEFT KNEE. AREAS IMPROVED AFTER 1HR. EQUIPMENT TAKEN TO BIO-MED FOR INSPECTION.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 9/13/02: CONTACTED BIOMEDICAL ENGINEERING AT USER FACILITY. DEPT EVALUATED DEVICE AFTER INCIDENT AND FOUND NO MECHANICAL PROBLEMS WITH EITHER SAFETY SHIELD OR MECHANISM SECURING SHIELD. USER MANUAL CONTAINS INSTRUCTIONS AND CAUTIONS RELATED TO INSTALLATION OF SHIELD. REVIEW OF SERVICE RECORDS AND SAFETY REPORTS FROM CUSTOMERS FOUND NO SIMILAR INCIDENTS. NO FURTHER ACTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PHOTOTHERAPY LIGHT LBI OLYMPIC MEDICAL CORP CTS-293115 *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DAY Other