BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIDMARK

    MDR report key: 21389193 · Received February 14, 2025

    Report

    Report Number
    1523530-2025-00001
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    January 22, 2025
    Report Date
    April 4, 2025
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EAZ
    UDI-DI
    00841709107344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON THE INITIAL REPORT OF THE DESCRIBED INSTANCE WITHIN INITIAL REPORT, 1523530-2025-00001 ON BEHALF OF MIDMARK CORPORATION, MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN FURTHER INFORMATION OF BOTH THE INJURY AND THE PRODUCT MALFUNCTION. IN THE LAST CORRESPONDENCE FROM THE CUSTOMER, IT WAS STATED THAT AFTER A REVIEW CONDUCTED BY CUSTOMERS OFFICE, IT DOES NOT APPEAR THAT ANY MALFUNCTION OF THE LIGHT OCCURRED THAT LED TO THE STUDENT INJURY. NO FURTHER ACTION TO BE TAKEN IN THIS INSTANCE.

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE AND DOCUMENTED TO OBTAIN FUTHER INFORMATION OF BOTH THE INJURY AND THE FALLING LIGHT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO US BY THE CUSTOMER. UPON FURTHER INFORMATION RECEIVED, MIDMARK CORPORATION WILL COMPLY WITH A FOLLOW UP REPORT AS APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MIDMARK CORPORATION THAT ON OR AROUND (B)(6) 2025, A LED DENTAL LIGHT FELL AND HURT A STUDENT AT A DENTAL COLLEGE. THE STUDENT RECEIVED A PINCH FROM THE LIGHT. NO FURTHER DETAILS OF THE SEVERITY OF THE INJURY HAS BEEN MADE AT THE TIME OF THE INITIAL REPORT. DUE TO PREVIOUS REPORTING OF LIKE INSTANCES OF LED DENTAL LIGHTS FALLING, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MIDMARK CORPORATION THAT ON OR AROUND (B)(6) 2025, A LED DENTAL LIGHT FELL AND HURT A STUDENT AT A DENTAL COLLEGE. THE STUDENT RECEIVED A PINCH FROM THE LIGHT. NO FURTHER DETAILS OF THE SEVERITY OF THE INJURY HAS BEEN MADE AT THE TIME OF THIS REPORT. DUE TO PREVIOUS REPORTING OF LIKE INSTANCES OF LED DENTAL LIGHTS FALLING, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624487 MIDMARK LED, DENTAL LIGHT EAZ MIDMARK CORPORATION 153901-003 00841709107344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other