BEUDAMED
    FDA Adverse Event Summary report: N

    MEDIVATORS RAPICIDE PA

    MDR report key: 3071140 · Received April 22, 2013

    Report

    Report Number
    2150060-2013-00001
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION WAS PROVIDED TO MANUFACTURER. MULTIPLE ATTEMPTS WERE MADE VIA TELEPHONE AND EMAIL. MANUFACTURER IS WAITING ON SECOND REPLY FROM OPERATOR FOR ADDITIONAL INFORMATION. IT WAS STATED IN INITIAL REPORT, OPERATOR HAD A LONGTERM EXPOSURE TO THE PRODUCT CAUSED FROM A SPILL FROM THE DRAIN. IT IS UNCLEAR AS TO HOW LONG THIS EXPOSURE WAS FOR AND AS TO WHY THE OPERATOR DID NOT REMOVE SELF FROM THE SPILL AREA WHILE CLEAN UP WAS OCCURING. IT IS ALSO UNKNOWN IF THE OPERATOR WAS WEARING PROPER PPE WHILE HANDLING THE CHEMICAL AS RECOMMENDED BY THE MANUFACTURER OR THE LENGTH OF TIME THE SPILL WAS NOT CONTAINED TO ALLOW A LONGTERM EXPOSURE TO OCCUR AS INDICATED BY OPERATOR. MEDIVATORS IS STILL WAITING RESPONSE TO THESE QUESTIONS. IT IS SUSPECTED THE OPERATOR WAS NOT WEARING THE PROPER PERSONAL PROTECTIVE EQUIPMENT AND PERHAPS THE SPILL WAS NOT PROMPTLY AND/OR PROPERLY CLEANED UP ACCORDING TO MANUFACTURERS RECOMMENDATION. MEDIVATORS DOES HAVE SPILL CLEAN UP DOCUMENTS AVAILABLE FOR CASES SUCH AS THIS ONE. HOWEVER, MEDIVATORS WAS NOTIFIED OF THE SPILL AFTER THE FACT BY A THIRD PARTY, CHEMTREC. BASED ON THE INFORMATION THAT WAS PROVIDED BY THE OPERATOR, IT IS SUSPECTED THE SPILL WAS CONTRIBUTED TO A FACILITY DRAIN ISSUE. MEDIVATORS AER UNITS REQUIRE DRAINING CONNECTION BY THE FACILITY. THE UNIT DRAINS FROM THE MACHINE INTO THE FACILITY DRAIN. IF THIS IS NOT CORRECTLY CONNECTED OR ALIGNED PROPERLY, DRAINING ISSUES MAY OCCUR AND ALLOW BACKFLOW OR USED SOLUTION TO SPILL ON THE FACILITY FLOOR BEHIND THE MACHINE. THERE WAS NO INDICATION THIS SPILL WAS CAUSED FROM AN INTERNAL MACHINE LEAK AND THE UNIT OPERATED TO SPECIFICATION. UPON RECEIPT OF ADDITIONAL INFORMATION, MEDIVATORS WILL REVIEW AND DETERMINE IF FURTHER ACTION IS NEEDED OR IF A SUPPLEMENTAL REPORT IS NECESSARY. CONSUMABLE DEVICE, NOT AVAILABLE.

    Description of Event or Problem · 1

    (B)(6) REPORT RECEIVED (B)(4) 2013 STATING: INHALATION EXPOSURE FOR AN EXTENDED PERIOD OF TIME. OPERATOR LOSS CONSCIOUSNESS AND SYMPTOMS INCLUDED HEADACHE, NAUSEA, NOSE BLEED, VOMITING AND TIGHTNESS IN CHEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171909 MEDIVATORS RAPICIDE PA PERACETIC ACID DISINFECTANT FEB MEDIVATORS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other