BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM CODE 1X18 ORANGE SMOOTH TOURNIQUET

    MDR report key: 8893073 · Received August 13, 2019

    Report

    Report Number
    MW5089002
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    August 8, 2019
    Report Date
    August 12, 2019
    Manufacturer
    PLATINUM CODE / IPC INC.
    Product Code
    GAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TOURNIQUETS ARE SLIPPING / COMING UNTIED DURING BLOOD DRAWS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683853 PLATINUM CODE 1X18 ORANGE SMOOTH TOURNIQUET TOURNIQUET, NONPNEUMATIC GAX PLATINUM CODE / IPC INC. 48NLO-FP 15772

    Patients

    Seq Age Sex Outcome Treatment
    1