BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGARD CORONARY FEMORAL STERILE BOWL

    MDR report key: 8707869 · Received June 17, 2019

    Report

    Report Number
    MW5087424
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 11, 2019
    Report Date
    June 13, 2019
    Manufacturer
    RESOURCE OPTIMIZATION AND INNOVATION, LLC
    Product Code
    OES
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496884 REGARD CORONARY FEMORAL STERILE BOWL CARDIAC CATHETERIZATION KIT OES RESOURCE OPTIMIZATION AND INNOVATION, LLC 67666B

    Patients

    Seq Age Sex Outcome Treatment
    1