BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL LOUPES

    MDR report key: 22862985 · Received August 21, 2025

    Report

    Report Number
    MW5175093
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 13, 2025
    Manufacturer
    ORASCOPTIC/METREX RESEARCH LLC
    Product Code
    FSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED LOUPES FROM ORASCOPTIC (B)(6) 2024 & NOTICED AN ALLERGIC REACTION AROUND (B)(6) 2025 ON THE SIDES OF MY NOSE & FOREHEAD FROM THE NICKEL IN THE NOSE PADS (WHICH WAS NOT MENTIONED ON THE LABEL THAT THEY CONTAINED NICKEL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403900 DENTAL LOUPES LOUPE, DIAGNOSTIC/SURGICAL FSP ORASCOPTIC/METREX RESEARCH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female Other BIRTH CONTROL.