BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIVATORS RAPICIDE PA

    MDR report key: 4110019 · Received September 23, 2014

    Report

    Report Number
    2150060-2014-00036
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    PMA / PMN Number
    K082988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THAT THE MEDIVATORS ADVANTAGE PLUS MACHINE OPERATORS/SCOPE TECHNICIANS ARE EXPERIENCING EXPOSURE SYMPTOMS TO THE RAPICIDE PA HIGH LEVEL DISINFECTANT. THESE SYMPTOMS INCLUDE BURNING THROATS/EYES, HEADACHES, AND NAUSEA. MEDIVATORS FIELD SERVICE ENGINEER WAS ONSITE TO INSPECT THE ADVANTAGE PLUS AERS THAT USE RAPICIDE PA. IT WAS REPORTED THAT THESE MACHINES WERE INSTALLED ROUGHLY 2 WEEKS AGO AND REPLACED CUSTOM ULTRASONIC UNITS RUNNING CIDEX OPA. THERE ARE NO LEAKS, AND BOTH MACHINES ARE FUNCTIONING PROPERLY. THE FSE ALSO REPORTED THAT "THERE IS NOTHING I EXPERIENCED DURING MY VISIT THAT HAD ME CONCERNED, AND I DID NOT NOTICE AN OVERWHELMING, OVERPOWERING CHEMICAL ODOR THAT WOULD HAVE ME CONCERNED FOR PATIENTS AND/OR USERS. THIS IS A NEW CUSTOMER WITH NEW CHEMISTRY AND A NEW REPROCESSING CYCLE." IT IS UNKNOWN AS TO WHETHER OR NOT THE USER/HANDLERS WERE WEARING THE APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT AS RECCOMENDED BY THE MANUFACTURER. MEDIVATORS HAS NO PRIOR COMPLAINTS OF LONG TERM AFFECTS OF RAPICIDE PA EXPOSURE. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    THE CASE STATES THAT USER/HANDLERS OF MEDIVATORS RAPICIDE PA AT THE FACILITY ARE EXPERIENCING EXPOSURE SYMPTOMS SUCH AS BURNING THROATS AND EYES, HEADACHES, AND NAUSEA FROM THE FUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590534 MEDIVATORS RAPICIDE PA HIGH LEVEL DISINFECTANT FEB MEDIVATORS ML02-0117

    Patients

    Seq Age Sex Outcome Treatment
    1 ADVANTAGE PLUS AER