BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANOSOL 3D

    MDR report key: 5284950 · Received December 7, 2015

    Report

    Report Number
    1521608-2015-00005
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 5, 2015
    Report Date
    December 1, 2015
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Product Code
    FTC
    PMA / PMN Number
    K872651
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR'S OFFICE REPORTED THAT THE PATIENT CONFIRMED THAT HE TREATED HIMSELF WITHOUT READING THE OPERATIONS MANUAL, AND DID NOT ADHERE TO THE TREATMENT GUIDELINES SET FORTH BY HIS DOCTOR. PER THE INSTRUCTION MANUAL AND THE GUIDELINES OF THE PHYSICIAN, THE MAXIMUM TREATMENT EXPOSURE SHOULD NOT HAVE EXCEEDED 2 MINUTES AND 13 SECONDS. THE DOCTOR'S OFFICE CONFIRMED THAT THE PATIENT TREATED FOR 10 MINUTES ON BOTH THE FRONT OF HIS BODY AND ANOTHER 10 MINUTES ON THE BACK OF HIS BODY. NBC REQUESTED ACCESS TO THE DEVICE TO CONDUCT AN EVALUATION; HOWEVER, THE REQUEST FOR ACCESS WAS DENIED. THE DEVICE HAD JUST BEEN DELIVERED TO THE PATIENT, SO NBC REVIEWED THE DHR AND TEST RECORDS FOR THE DEVICE AND WAS ABLE TO CONFIRM THAT THE DEVICE WAS FUNCTION AS INTENDED 76 DAYS BEFORE THE EVENT. THE DOCTOR'S OFFICE AND NBC STRONGLY BELIEVE THAT THE PATIENT INJURY WAS CLEARLY A RESULT OF MISUSE OF INSTRUCTIONS FOR USE AS IT PERTAINS TO TREATMENT PROTOCOL.

    Description of Event or Problem · 1

    NATIONAL BIOLOGICAL CORPORATION RECEIVED A CALL FROM A DOCTOR'S OFFICE REGARDING A PATIENT INJURY. THE PATIENT WAS USING PANOSOL 3D SYSTEM, MODEL; UVB-631 AND WAS BURNED. THE EXACT LOCATION AND DEGREE OF BURNS ARE NOT KNOWN AT THIS TIME, BUT THE DOCTOR'S OFFICE DID INFORM NBC THAT THE PATIENT WAS TREATED IN THE ICU. CURRENT STATUS OF THE PATIENT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT, BUT NBC WAS ABLE TO CONFIRM THAT THE PATIENT WAS RELEASED HOME DURING A FOLLOW-UP CALL WITH THE DOCTOR'S OFFICE, ((B)(6) 2015).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801872 PANOSOL 3D FTC NATIONAL BIOLOGICAL CORP. UVB-631 10005

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention