BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICOM SAFEMASK TAILORMADE

    MDR report key: 19315348 · Received May 14, 2024

    Report

    Report Number
    9611959-2024-00001
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 17, 2024
    Report Date
    June 18, 2024
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    FXX
    UDI-DI
    10686864036415
    PMA / PMN Number
    K051291
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON APRIL 19, 2024, AMD MEDICOM INC. RECEIVED THE EVENT THAT TWO FEMALES IN THE OFFICE HAD FACIAL SWELLING AND BREATHING ISSUES AFTER WEARING THE MASKS. ONE FEMALE HAD TO SEE A PHYSICIAN AND WAS PLACED ON MEDICATION. THEY ARE STILL EXPERIENCING RASH BREAKOUTS.

    Additional Manufacturer Narrative · 0

    ON APRIL 19, 2024, AMD MEDICOM INC. RECEIVED THE EVENT THAT TWO FEMALES IN THE OFFICE HAD FACIAL SWELLING AND BREATHING ISSUES AFTER WEARING THE MASKS. ONE FEMALE HAD TO SEE A PHYSICIAN AND WAS PLACED ON MEDICATION. THEY ARE STILL EXPERIENCING RASH BREAKOUTS. ADDITIONAL INFORMATION: 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 TO THE MASK BEING CYTOTOXIC, SKIN IRRITANT OR SKIN SENSITIZER. PRODUCTION RECORDS AND DESIGN HISTORY FILE WERE VERIFIED AND NO OBSERVATIONS WERE NOTED. NO SIMILAR COMPLAINT WAS OBSERVED DURING HISTORICAL REVIEW OF COMPLAINTS. BASED ON THE INVESTIGATION, NO ROOT CAUSE WAS IDENTIFIED. NOTE: NAME/ADDRESS OF THE MANUFACTURING SITE WAS CORRECTED.

    Description of Event or Problem · 0

    TWO FEMALES IN THE OFFICE HAD FACIAL SWELLING AND BREATHING ISSUES AFTER WEARING THE MASKS. 1 FEMALE HAD TO SEE A PHYSICIAN AND WAS PLACED ON MEDICATION. THEY ARE STILL EXPERIENCING RASH BREAKOUTS.

    Description of Event or Problem · 0

    TWO FEMALES IN THE OFFICE HAD FACIAL SWELLING AND BREATHING ISSUES AFTER WEARING THE MASKS. 1 FEMALE HAD TO SEE A PHYSICIAN AND WAS PLACED ON MEDICATION. THEY ARE STILL EXPERIENCING RASH BREAKOUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548592 MEDICOM SAFEMASK TAILORMADE EARLOOP FACE MASK FXX AMD MEDICOM INC. 3828 10686864036415

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention