BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS ENDO CARRY-ON PROCEDURE KIT

    MDR report key: 7713918 · Received July 23, 2018

    Report

    Report Number
    MW5078527
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    July 19, 2018
    Report Date
    July 20, 2018
    Manufacturer
    MEDIVATORS
    Product Code
    OCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGICAL UNIT WAS PREPPING FOR ENDO PROCEDURE. ENDO KIT WAS OPENED AND STAFF MEMBER OBSERVED A FLY ON A 4X4. MEDIVATORS INC., REF CPK-107520-0001, LOT #918726, EXP 03/20/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555045 MEDIVATORS ENDO CARRY-ON PROCEDURE KIT ENDOSCOPIC IRRIGATION/ SUCTION SYSTEM OCX MEDIVATORS 918726

    Patients

    Seq Age Sex Outcome Treatment
    1