BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIRST STEP ENDOSCOPE PRECLEAN KIT

    MDR report key: 5510738 · Received March 15, 2016

    Report

    Report Number
    MW5060947
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 15, 2016
    Manufacturer
    CYGNUS MEDICAL
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    AN OPENED CHOCOLATE CANDY BAR WRAPPER WITH BROKEN PIECES OF CHOCOLATE CANDY INSIDE WE FOUND INSIDE A SEALED STERILE CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158027 FIRST STEP ENDOSCOPE PRECLEAN KIT ENDOSCOPE PRECLEAN KIT LRP CYGNUS MEDICAL EP-6W

    Patients

    Seq Age Sex Outcome Treatment
    1