BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN PINKFIN ELITE

    MDR report key: 10648177 · Received October 7, 2020

    Report

    Report Number
    MW5097136
    Event Type
    Injury
    Date Received
    October 7, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 5, 2020
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HANDLE ON PINKFIN DEVICE FAILED, CAUSING PATIENT'S LEG TO FALL TOWARDS THEIR HEAD DURING SURGERY PREP. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104741 ALLEN PINKFIN ELITE OPERATING ROOM ACCESSORIES TABLE TRAY FWZ ALLEN MEDICAL SYSTEMS, INC. PINKFIN ELITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention