BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CHECK WRAP

    MDR report key: 5048731 · Received September 2, 2015

    Report

    Report Number
    5048731
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    June 1, 2015
    Report Date
    August 17, 2015
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    FRG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO SURGERY, THERE WERE FREQUENT DISCOVERIES OF HOLES AND OR TEARS IN THIS PAPER PRODUCT WHICH COVERS THE INSTRUMENT TRAYS DURING STERILE PROCESSING. THIS RESULTED IN THE NEED FOR IMMEDIATE USE STEAM STERILIZATION. AFTER HAVING SWITCHED TO THE KC600 CAT #34147 FROM THE SAME COMPANY, WE HAVE NOT HAD ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580386 QUICK CHECK WRAP WRAP, STERILIZATION FRG HALYARD HEALTH, INC. KC500

    Patients

    Seq Age Sex Outcome Treatment
    1