BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

    MDR report key: 535974 · Received July 22, 2004

    Report

    Report Number
    1226354-2004-00001
    Event Type
    Injury
    Date Received
    July 22, 2004
    Date of Event
    June 24, 2004
    Report Date
    July 22, 2004
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CO EMPLOYEE WAS INSTALLING A BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR UNIT IN A PHYSICIAN'S OFFICE IN 2004. THEY POSITIONED THE CARTON CONTAINING THE BASE UNIT OF THE DEVICE ON ITS SIDE IN ORDER TO OPEN THE SHIPPING CONTAINER BOX. UPON OPENING THE SHIPPING BOX, THE BASE UNIT FELL OVER AND LANDED ON THE EMPLOYEE'S HAND, SEVERING THEIR FINGERTIP OF THE LEFT MIDDLE FINGER. THE FINGERTIP WAS SEVERED UNDERNEATH THE FINGERNAIL BEFORE THE JUNCTION OF THE KNUCKLE. EMERGENCY PERSONNEL TOOK PT TO AN ER WHERE THE TIP WAS SUTURED AND REATTACHED TO THE REST OF THE DIGIT. THEY WERE TREATED WITH ORAL CEPHALEXIN 500MG, 4 TIMES PER DAY, FOR INFECTION PROPHYLAXIS AND HYDROCODONE W/APAP FOR PAIN AS NEEDED. REPORTED THAT BETWEEN 6/04 AND 07/04, THEY WERE EVALUATED AND TREATED BY A PLASTIC SURGEON WITH A ERCHONIA LOW LEVEL LASER DEVICE FOR A TOTAL OF 6 VISITS FOR A "BLACK AND PURPLE FINGER WITH GANGRENE." PT REPORTED AS OF 7/04, THE SKIN WAS DESCRIBED AS BEING PINK WITH BLOOD AROUND THE SUTURE AND NO SIGNS OF GANGRENE. THE STITCHES WERE REMOVED NINETEEN DAYS LATER AND SOME DEAD SKIN WAS REMOVED FROM THE TIP OF THE FINGER. TWO DAYS AFTERWARDS THE EMPLOYEE CONTINUES TO HEAL AND HAVE WEEKLY MEDICAL EVALUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR BLUE LIGHT THERAPY DEVICE MVF DUSA PHARMACEUTICALS, INC. 4170-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention