BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY

    MDR report key: 667132 · Received January 19, 2006

    Report

    Report Number
    1226354-2006-00001
    Event Type
    Injury
    Date Received
    January 19, 2006
    Date of Event
    December 15, 2005
    Report Date
    January 19, 2006
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN DECEMBER 2005, AN INSTALLATION TECHNICIAN WAS PERFORMING AN INSTALL OF THE BLU-U PHOTODYNAMIC THERAPY ILLUMINATOR AT A PHYSICIAN'S OFFICE. THE TECHNICIAN REPORTED THE FOLLOWING EVENT. DURING THE INSTALLATION, THE TECHNICIAN WAS HOLDING THE BASE UNIT ON ITS SIDE WHILE INSTALLING THE CASTERS. THE BASE UNIT REPORTEDLY "SLIPPED" ON THE CARPET AND THE TECHNICIAN TRIED TO CATCH THE UNIT WITH HIS RIGHT HAND. THE BASE UNIT LANDED ON THE TECHNICIAN'S RIGHT HAND, INJURYING THE MIDDLE AND RING FINGERS. THE TECHNICIAN WAS TREATED BY THE PHYSICIAN AT THE OFFICE, WHO STITCHED BOTH FINGERS AND BANDAGED THE HAND. THE TECHNICIAN STATED HE EXPERIENCED PAIN, TINGLING AND LOSS OF SENSATION IN BOTH FINGERS. THE TECHNICIAN WAS TREATED AT A FOLLOW-UP APPOINTMENT IN ABOUT TWO WEEKS LATER FOR A DRESSING CHANGE AND REPORTED THAT NURSE STATED HIS FINGERS "WERE COMING ALONG" (HEALING). HE HAD ANOTHER FOLLOW-UP APPOINTMENT SCHEDULED IN A WEEK LATER TO REMOVE THE STITCHES. AS OF ABOUT A WEEK AFTER THE INCIDENT, THE TECHNICIAN STATED HE WAS HEALING, HOWEVER, HE STILL FELT SORNESS, TINGLING AND LOSS OF SENSATION IN BOTH FINGERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention