BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES

    MDR report key: 7933444 · Received October 4, 2018

    Report

    Report Number
    7933444
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 26, 2018
    Report Date
    September 26, 2018
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGICAL MASK HAS A METAL PIECE ON BOTH INTERNAL SIDES OF THE MASK THAT CAUSED FACIAL LACERATIONS OF SOME STAFF DURING NORMAL WEAR FOR INVASIVE PROCEDURES. WE ARE PULLING THE PRODUCT FROM OUR INVENTORY. A DESIGN CHANGE TO MITIGATE THE RISK OF INJURY TO CLINICAL STAFF HAS BEEN REQUESTED. PER HOSPITAL, INFORMED PRODUCT WAS BEING REMOVED FROM CLINICAL DEPARTMENTS AND INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777861 LEVEL I SURGICAL MASK ANTI-FOG FOAM TIES MASK, SURGICAL FXX CARDINAL HEALTH 200, LLC AT71235, AT752005 1071235, 1752005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other