BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELCH ALLYN, INC.

    MDR report key: 9681173 · Received February 7, 2020

    Report

    Report Number
    9681173
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Date of Event
    January 10, 2020
    Report Date
    January 21, 2020
    Manufacturer
    WELCH ALLYN, INC.
    Product Code
    HMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE A PATIENT WAS BEING TRANSFERRED FROM OUR EMERGENCY DEPARTMENT TO ANOTHER OF OUR FACILITIES, A LARGE BLISTER WAS FOUND ON THE PATIENT'S WRIST. IT WAS BELIEVED IT COULD HAVE HAPPENED WHILE THE PATIENT WAS BEING SEEN IN THE EMERGENCY DEPARTMENT. AFTER AN INVESTIGATION, IT WAS DETERMINED ONE POSSIBILITY FOR THE BURN CAME FROM AN OTOSCOPE USED TO TRANSILLUMINATE THROUGH THE PATIENT'S PALM. OUR FACILITY HAS SINCE DIRECTED STAFF NOT TO USE AN OTOSCOPE AS A VEIN VIEWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147618 WELCH ALLYN, INC. STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC HMF WELCH ALLYN, INC. 901027

    Patients

    Seq Age Sex Outcome Treatment
    1 365 DA Other