BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD BOWL GUIDEWIRE

    MDR report key: 8717350 · Received June 18, 2019

    Report

    Report Number
    MW5087487
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 11, 2019
    Report Date
    June 14, 2019
    Manufacturer
    ROI CONSOLIDATED SERVICE CENTER (CSC)
    Product Code
    OES
    UDI-DI
    10326053113984
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DID NOT REACH PT. SMALL PARTICLE FOUND IN STERILE BOWL PRIOR TO CASE START. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499884 REGARD BOWL GUIDEWIRE CARDIAC CATHTERIZATION KIT OES ROI CONSOLIDATED SERVICE CENTER (CSC) HT0951 67666B 10326053113984

    Patients

    Seq Age Sex Outcome Treatment
    1