BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNOL DUCKBILL

    MDR report key: 1233448 · Received November 5, 2008

    Report

    Report Number
    1233448
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 2, 2008
    Report Date
    November 5, 2008
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    FXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE KIMBERLY CLARK TECNOL DUCKBILL SURGICAL MASKS ARE SPLITTING AT THE SIDE SEAM.======================MANUFACTURER RESPONSE FOR FOG-FREE SURGICAL MASK, TECNOL DUCKBILL======================MANUFACTURER PROVIDED RGA# FOR RETURN EVALUATION OF PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNOL DUCKBILL MASK, SURGICAL FXX KIMBERLY-CLARK CORPORATION 49216 AM7345B23

    Patients

    Seq Age Sex Outcome Treatment
    1 *