BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 17890350 · Received October 6, 2023

    Report

    Report Number
    9611959-2023-00001
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    September 4, 2023
    Report Date
    December 12, 2023
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    UDI-DI
    10304040138912
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 19, 2023, AMD MEDICOM INC. RECEIVED THE EVENT THAT A DENTIST HAD A MILD SKIN IRRITATION AFTER USING THE HENRY SCHEIN MAXIMA EARLOOP MASKS. ON SEPTEMBER 27, 2023 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DENTIST HAD A RASH ON HER FACE AND HAD AN ASTHMA ATTACK AND NEEDED TO TAKE ALBUTEROL AS A RESULT. AN INVESTIGATION WAS CONDUCTED. BIOCOMPATIBILITY (CYTOTOXICITY, SKIN IRRITATION AND SKIN SENSITIZATION) TEST RESULTS WERE VERIFIED ON THE MASK CONSTRUCTIONS FOR THIS PRODUCT AND THE RESULTS DID NOT REVEAL ANY BIOLOGICAL RISKS WITH RESPECT TOT HE MASK BEING CYTOTOXIC, SKIN IRRITANT OR SKIN SENSITIZER. THE BATCH RECORDS AND DESIGN HISTORY FILE WERE VERIFIED AND NO ABNORMALITY WAS NOTED. IN ADDITION, TESTING WAS PERFORMED ON THE RETURNED SAMPLES WHERE A BLIND TEST WAS CONDUCTED (I.E. RETURNED SAMPLES WORN BY INDIVIDUALS BLINDED TO THE SAMPLES). THE BLIND TEST CONCLUDED THAT NONE OF THE PARTICIPANTS FELT ITCHY OR UNCOMFORTABLE FOLLOWING WEARING THE MASKS AFTER 8 HOURS. BASED ON THE INVESTIGATION, NO ROOT CAUSE WAS IDENTIFIED. NO QUALITY ISSUE NOR DEFECT OF THE FUNCTIONALITY WITH THE DEVICE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 19, 2023, AMD MEDICOM INC. RECEIVED THE EVENT THAT A DENTIST HAD A MILD SKIN IRRITATION AFTER USING THE HENRY SCHEIN MAXIMA EARLOOP MASKS. ON SEPTEMBER 27, 2023 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DENTIST HAD A RASH ON HER FACE AND HAD AN ASTHMA ATTACK AND NEEDED TO TAKE ALBUTEROL AS A RESULT. AN INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 0

    A 40 YEAR OLD FEMALE DENTIST HAD A MILD SKIN IRRITATION AND RASH ON HER FACE AFTER WEARING THE MASKS AS WELL AS HAVE AN ASTHMA ATTACK. THE DURATION OF THE SYMPTOMS WERE FOR TWO DAYS UNITL SHE NOTICED THE CORRELATION TO THE MASKS. SHE NEEDED TO TAKE ABUTEROL TO HELP AND HAS SINCE GOTTEN BETTER.

    Description of Event or Problem · 0

    A 40 YEAR OLD FEMALE DENTIST HAD A MILD SKIN IRRITATION AND RASH ON HER FACE AFTER WEARING THE MASKS AS WELL AS HAVE AN ASTHMA ATTACK. THE DURATION OF THE SYMPTOMS WERE FOR TWO DAYS UNTIL SHE NOTICED THE CORRELATION TO THE MASKS. SHE NEEDED TO TAKE ABUTEROL TO HELP AND HAS SINCE GOTTEN BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238606 HENRY SCHEIN MAXIMA EARLOOP MASK FXX AMD MEDICOM INC. T2303 10304040138912

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention