BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 25056435 · Received May 1, 2026

    Report

    Report Number
    2954762-2026-00002
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    March 31, 2026
    Report Date
    May 4, 2026
    Manufacturer
    AMD MEDICOM
    Product Code
    FXX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE INITIAL REPORT SUBMITTED ON 05/01/2026 HAD A SENTENCE IN SECTION B5 THAT NEEDS TO BE REVISED. THE ORIGINAL STATEMENT "THE GLOVES ARE STORED IN ACCORDANCE WITH STANDARD PRACTICE IN CLEAN, TEMPERATURE CONTROLLED ENVIRONMENT." SHOULD BE CHANGED TO "THE MASKS ARE STORED IN ACCORDANCE WITH STANDARD PRACTICE IN CLEAN, TEMPERATURE CONTROLLED ENVIRONMENT".

    Description of Event or Problem · 0

    THIS REPORT RELATES TO 2954762-2026-00001 AS THIS IS THE OTHER DEVICE THAT WAS USED BY THE FEMALE DOCTOR. A FEMALE DOCTOR REPORTS THAT THE MASKS CAUSED HER BOTH SKIN AND EYE IRRITATION. THE REACTION EXPERIENCED WAS SKIN RASH, BREAKOUT, AND ALLERGIC TYPE REACTION. THE SYMPTOMS WERE REPORTED SHORTLY AFTER USED AND WERE LOCALIZED TO THE AREAS OF CONTACT. THE DOCTOR ALLEGES THAT THE REACTION WAS SIGNIFICANT ENOUGH TO SEEK MEDICAL EVALUATION. THE GLOVES ARE STORED IN ACCORDANCE WITH STANDARD PRACTICE IN CLEAN, TEMPERATURE CONTROLLED ENVIRONMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385550 HENRY SCHEIN CRITERION EARLOOP MASK L3 TWN FXX AMD MEDICOM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention