BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    FLEXSYS

    MDR report key: 16730497 · Received April 13, 2023

    Report

    Report Number
    3011024620-2023-00001
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 16, 2023
    Report Date
    April 13, 2023
    Manufacturer
    GME GERMAN MEDICAL ENGINEERING GMBH
    Product Code
    FTC
    PMA / PMN Number
    K221623
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS SEE: ATTACHED FILE "ANALYSIS ON ADVERSE EVENT 230316"

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS INITIALLY REPORTED TO GME VIA WHATSAPP FROM OUR DISTRIBUTOR FOR MIDDLE EAST, TOGETHER WITH AN IMAGE OF BURN MARKS AT THE (LOWER) BACK OF A FEMALE PATIENT. "CHILD 7 YEARS OLD, HAS PSORIASIS AS PER THE DOCTOR. MED TEST APPLIED, SKIN TYPE 3-4 AS PER THE PICTURE, MED SHOULD BE LESS THAN 200 MJ/CM² PARAMETERS USED TO TREAT 1,350 MJ/CM² FOR NO REASONS. IT IS NEW CUSTOMER WHO PURCHASED THE FLEXSYS WITH 308 NM APPLICATOR, AND THIS IS THE FIRST TREATMENT. I INVESTIGATED THE CASE AS PER THE DOCTOR REQUEST TO FIND OUT WHO DID THIS MISTAKE AND DISCOVERED THAT THE NURSE DOESN'T UNDERSTAND MED IN PROPER WAY.. SHE IS GOING TO SELECT THE HIGHEST VALUE OF MED INSTEAD THE LOWEST." THE ATTACHED IMAGE SHOWS THE MED-TEST WAS CARRIED OUT ON SLIGHTLY DARKER SKIN THAN THE TREATMENT AREA. LOWEST MED-DOSE SHOWS LIGHT SKIN REACTION ALREADY. TREATMENT OF 26 LOCATIONS RESULTED IN CIRCULAR BURN MARKS (~15MM DIAMETER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456488 FLEXSYS FLEXSYS UVB EPL 308 NM FTC GME GERMAN MEDICAL ENGINEERING GMBH 1070, 1071

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female Required Intervention