BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MASK, FULL FACE W/VELCRO STRAP VENTED FOAM

    MDR report key: 4617513 · Received March 16, 2015

    Report

    Report Number
    1060680-2015-00003
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Date of Event
    February 13, 2015
    Report Date
    March 13, 2013
    Manufacturer
    EMBRACE HEALTHCARE LLC
    Product Code
    LYU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED FOR SALES AND SIMILAR COMPLAINT INFORMATION. (B)(4). THERE HAVE BEEN NO PREVIOUS QUALITY REPORTS FOR THE DEVICE. WITHIN THE TEXT OF THE COMPLAINT, IT IS STATED, "DR. WEARING SHIELD AS NORMAL WEARS SHIELD. ACCOUNT WAS USING OUR SHIELDS IN PLACE OF THEIR NORMAL FACE SHIELD THAT WAS ON BACK ORDER (SPLASH SHIELD IN IS NAME OF THEIR NORMAL USED FACE SHIELD.) OUR FACE SHIELD AS DESCRIBED BY ACCOUNT AS TOO FLIMSY AND TOO MUCH OF A GAP FROM FRONT SHIELD AND FACE ALLOWING FLUID TO SPLASH UP ON FACE. ACCOUNT HAS ASKED FOR US TO TAKE BACK ANY OPEN CASES OF PRODUCT." THE ABOVE STATEMENT INDICATES THAT THE DEROYAL PRODUCT WAS BEING UTILIZED INSTEAD OF AN ALTERNATE VENDOR'S PRODUCT. IT IS UNKNOWN IF THE AFFECTED INDIVIDUAL FOLLOWED THE PROVIDED IFU TO APPLICATION OF THE DEVICE. IN ADDITION, THE IFU STATES, "THE DEROYAL FACE SHIELD IS INTENDED TO REDUCE POTENTIAL EXPOSURE AGAINST SPLASHES, SPLATTER, AND DROPLETS OF BLOOD OR OTHER BODILY FLUIDS."CORRECTION: A CREDIT HAS BEEN PROVIDED FOR ONE EACH. ROOT CAUSE ANALYSIS: THE REPORT HAS BEEN DETERMINED TO BE AN ISOLATED EVENT. A POTENTIAL ROOT CAUSE FOR THE ISSUE HAS BEEN IDENTIFIED AS END USER ERROR. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A PREVENTIVE ACTION HAS NOT BEEN TAKEN.

    Description of Event or Problem · 1

    DR. (B)(6) WAS EXPOSED TO FLUID FROM BEING SPRAYED UNDER THE FACE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179592 MASK, FULL FACE W/VELCRO STRAP VENTED FOAM ACCESSORY, SURGICAL APPAREL LYU EMBRACE HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1