BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT, ULTRAVIOLET, DERMATOLOGICAL

    MDR report key: 3788367 · Received April 28, 2014

    Report

    Report Number
    MW5035886
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 25, 2014
    Manufacturer
    DUSA PHARMACEUTICALS
    Product Code
    MVF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED EXPERIENCE AFTER RECEIVING A DERMATOLOGY TREATMENT TO REMOVE A CANCEROUS SPOT ON HIS FACE. COMPLAINANT WAS TREATED WITH A DEVICE CALLED LEVULAN KERASTICK (AMINOLEVULINIC ACID HCI) FOR TOPICAL SOLUTION, 20%. THE CANCEROUS SPOT WAS REMOVED THEN TREATED WITH THIS DEVICE. PER COMPLAINANT, ACID WAS APPLIED TO HIS FACE AND LEFT ON FOR 1 HOUR. FACE WAS THEN TREATED WITH A BLUE LIGHT AND AN EYE PROTECTOR. WHICH COMPLAINANT STATED DID NOT FIT PROPERLY. COMPLAINANT STAYED UNDER THE BLUE LIGHT LAMP FOR 16 MINUTES. SINCE TREATMENT, HE HAS EXPERIENCED BLURRY EYES. HIS DOCTOR ADVISED HIM THAT SYMPTOM WOULD BE TEMPORARY AND SHOULD CLEAR UP AFTER TWO WEEKS. IT HAS BEEN LONGER THAN TWO WEEKS AND SYMPTOM HAS NOT IMPROVED. COMPLAINANT BELIEVES SYMPTOM WAS CAUSED BY THE EYE PROTECTION NOT FITTING CORRECTLY DURING THE PROCEDURE AND/OR ACID GOT INTO HIS EYES. EITHER SPECULATION, COMPLAINANT REPORTS ONGOING ISSUES WITH BLURRY EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253535 LIGHT, ULTRAVIOLET, DERMATOLOGICAL ULTRAVIOLET LIGHT MVF DUSA PHARMACEUTICALS 822801

    Patients

    Seq Age Sex Outcome Treatment
    1 TOPICAL SOLUTION 20%.| LEVULAN KERASTICK (AMINOLEVULINIC ACID HCI) FOR