BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR

    MDR report key: 7378414 · Received March 28, 2018

    Report

    Report Number
    1226354-2018-00008
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 28, 2018
    Manufacturer
    DUSA PHARMACEUTICALS, LNC.
    Product Code
    MVF
    PMA / PMN Number
    P99001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WENT IN FOR HER SECOND TREATMENT FOR ACTINIC KERATOSIS. PATIENT STATED THAT THE PRODUCT WAS LEFT ON HER FACE FOR 2 HOURS AND THEN SHE WENT BACK TO RECEIVE THE BLU-U TREATMENT. WHEN SHE WENT BACK FOR THE LIGHT TREATMENT, THE MEDICAL STAFF WAS UNABLE TO GET THE LIGHT TO TURN ON. THEY INCUBATED HER FOR AN ADDITIONAL 30 MINUTES WHILE THEY ATTEMPTED TO GET THE MACHINE TO FUNCTION PROPERLY, HOWEVER IT NEVER TURNED ON SO SHE WAS UNABLE TO RECEIVE THE BLU-U TREATMENT. THE PATIENT IS EXPERIENCING FACE IS BEET RED AND BURNING SIMILAR TO A SUNBURN. FOLLOW-UP ((B)(4); 27-FEB-18): NO SIGNIFICANT INFORMATION WAS RECEIVED.

    Description of Event or Problem · 1

    WRONG TECHNIQUE IN DRUG USAGE PROCESS, DEVICE FAILURE, REACTION NONSPECIFIC, RED FACE, BURNING SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219713 BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATOR BLU-U MVF DUSA PHARMACEUTICALS, LNC.

    Patients

    Seq Age Sex Outcome Treatment
    1