BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAAVLIN

    MDR report key: 4471077 · Received January 28, 2015

    Report

    Report Number
    1526255-2015-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 14, 2015
    Manufacturer
    DAAVLIN DISTRIBUTING COMPANY
    Product Code
    FTC
    PMA / PMN Number
    K828654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A 1,500MJ DOSE OF NARROW BAND UVB LIGHT WOULD TYPICALLY BE REACHED WITHIN 3-4 WEEKS OF NARROW BAND UVB TREATMENT OF A FITZPATRICK SKIN TYPE II PATIENT. IT IS A DOSE THAT MIGHT BE DELIVERED TO A TREATMENT NAIVE SKIN TYPE II PATIENT AS A PART OF PHOTOPATCH TESTING, OR DIRECTLY TO A PSORIATIC LESION WITH A TARGETED LIGHT SOURCE, BUT IT WOULD BE EXPECTED TO CAUSE ERYTHEMA IN NON-LESIONAL SKIN. THE DEVICE ASSOCIATED WITH THIS REPORT HAS BEEN REGULARLY SERVICED AND CALIBRATED, PRIOR TO AND AFTER THE EVENT IN QUESTION, BY DAAVLIN AUTHORIZED SERVICE TECHNICIANS AND HAS BEEN DETERMINED TO BE IN GOOD WORKING CONDITION. THE CONCLUSION IS THAT THIS EVENT IS ATTRIBUTABLE TO HUMAN FACTORS ISSUES WHERE USE ERROR, THE INTERACTION BETWEEN THE DEVICE AND USER, DIRECTLY CAUSED THE EVENT. THE TREATING PHYSICIANS AGREE AND ARE ALL OF THE OPINION THAT THE OVERDOSE WAS STRICTLY DUE TO OPERATOR USE ERROR. IN SO MUCH AS THE DEVICE CONTRIBUTED TO THE EVENT, IT WAS ONLY BY MEANS OF OPERATOR USE ERROR/ MISUSE. THERE WAS NO DIRECT FAILURE ATTRIBUTABLE TO THE DEVICE ITSELF AND IT HAS BEEN DETERMINED THAT THE DEVICE OPERATED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PHYSICIAN INFORMED DAAVLIN THAT A PATIENT HAS INITIATED MALPRACTICE LITIGATION AGAINST SAID PHYSICIAN FOR ALLEGED BURNS FOLLOWING AN ACCIDENTAL OVERDOSE. PER PHYSICIAN, AND CIVIL COURT FILINGS, THE PATIENT ALLEGES THAT SYMPTOMS OF ERYTHEMA HAVE LASTED LONGER THAN 7 DAYS THOUGH THE TREATING PHYSICIAN DENY THE SEVERITY OF THE SYMPTOMS. THIS INCIDENT TOOK PLACE DURING THE PATIENTS FIRST TREATMENT. INTERNAL OFFICE PROTOCOL INDICATES THAT 150MJ OF NARROW BAND UVB TREATMENT WAS PRESCRIBED FOR THE FIRST TREATMENT, HOWEVER, THE OPERATOR DELIVERED 1,500MJ NARROW BAND UVB TREATMENT. THE DEVICE ASSOCIATED WITH THIS REPORT HAS BEEN REGULARLY SERVICED AND CALIBRATED, PRIOR TO AND AFTER THE EVENT IN QUESTION, BY DAAVLIN AUTHORIZED SERVICE TECHNICIANS AND HAS BEEN DETERMINED TO BE IN GOOD WORKING CONDITION. THE TREATING PHYSICIANS AGREE AND ARE ALL UNDER THE OPINION THAT THE OVERDOSE WAS STRICTLY DUE TO OPERATOR USE ERROR. IN SO MUCH AS THE DEVICE CONTRIBUTED TO THE ERROR, IT WAS ONLY BY MEANS OF OPERATOR MISUSE/ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66026 DAAVLIN SPECTRA, 311/350 FTC DAAVLIN DISTRIBUTING COMPANY SPECTRA, 311/350

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization