BEUDAMED
    FDA Adverse Event Summary report: N

    REGARD CORONARY FEMORAL KIT

    MDR report key: 8707876 · Received June 17, 2019

    Report

    Report Number
    MW5087425
    Date Received
    June 17, 2019
    Date of Event
    June 1, 2019
    Report Date
    June 13, 2019
    Manufacturer
    RESOURCE OPTIMIZATION & INNOVATION, LLC
    Product Code
    OES
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DID NOT REACH THE PT. SMALL BLACK PARTICLE FOUND IN STERILE BOWL PRIOR TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496957 REGARD CORONARY FEMORAL KIT CARDIAC CATHETERIZATION KIT OES RESOURCE OPTIMIZATION & INNOVATION, LLC 64671B

    Patients

    Seq Age Sex Outcome Treatment
    1