BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID 300/2 DRYING CABINET

    MDR report key: 23907476 · Received December 29, 2025

    Report

    Report Number
    3008241044-2025-00002
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    November 19, 2025
    Report Date
    January 23, 2026
    Manufacturer
    STEELCO S.P.A.
    Product Code
    MEC
    UDI-DI
    08051520012693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE TECHNICIAN WAS NOT AWARE THAT HE SHOULD NOT LOOK INTO THE UV LAMP WITHOUT PROTECTIVE EYEWEAR. PERSONNEL WILL BE TRAINED. APPROPRIATE TERMS/CODES ARE NOT AVAILABLE FOR ADVERSE EVENT PROBLEM CATEGORIES "MEDICAL DEVICE PROBLEM CODE" AND "INVESTIGATION FINDINGS." WE SUGGEST: PROBLEM CODE: "PROBLEM ASSOCIATED WITH FAILURE TO USE PROTECTIVE EYEWEAR" INVESTIGATION FINDINGS CODE: "INADEQUATE TRAINING OF TECHNICAL SERVICE PERSONNEL."

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL REQUIRED INFORMATION PREVIOUSLY NOT AVAILABLE. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B3, B4, D4, G3, G6, H2, AND H4.

    Description of Event or Problem · 0

    WHILE TROUBLESHOOTING AN ID 300/2 DRYING CABINET THAT DISPLAYED AN ERROR RELATED TO THE UV LAMP, THE TECHNICIAN REMOVED THE BPA FILTER TO CHECK IF ALL THREE LAMPS WERE FUNCTIONING. THE TECHNICIAN OBSERVED THE LAMPS FOR LESS THAN FIVE SECONDS ON THREE SEPARATE OCCASIONS BEFORE CLOSING THE SYSTEM. EXPOSURE TO THE UV LIGHT, EVEN FOR THESE BRIEF MOMENTS, RESULTED IN MILD PHOTOKERATITIS (A SENSATION SIMILAR TO HAVING SAND IN THE EYES). THE IRRITATION WAS TEMPORARY, WITH NO PERMANENT DAMAGE, AND VISION RETURNED TO NORMAL. ACCORDING TO THE DOCTOR'S NOTE, THE TECHNICIAN WAS CLEARED TO RETURN TO WORK THE SAME DAY. NO PATIENTS WERE INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510482 ID 300/2 DRYING CABINET INSTRUMENT DRYING CABINET MEC STEELCO S.P.A. ID 300/2 08051520012693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown