BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAPICIDE PA HIGH LEVEL DISINFECTANT

    MDR report key: 12725401 · Received October 30, 2021

    Report

    Report Number
    2150060-2021-00025
    Event Type
    Injury
    Date Received
    October 30, 2021
    Date of Event
    October 1, 2021
    Report Date
    October 30, 2021
    Manufacturer
    MEDIVATORS INC
    Product Code
    FEB
    UDI-DI
    00677964090172
    PMA / PMN Number
    K082988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN HOW THE DISINFECTANT CAME INTO CONTACT WITH THE EMPLOYEE'S SKIN. THE DURATION OF THE REPORTED SKIN REDNESS AND IRRITATION WAS NOT PROVIDED. FOLLOWING THE EVENT, THE USER CONTACTED CHEMTREC AND WAS PROVIDED THE RAPICIDE PA PART A SDS. THE EMPLOYEE SOUGHT MEDICAL ATTENTION AND A BANDAGE TO THE AFFECTED AREA WAS APPLIED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED. IT IS NOT KNOWN IF THE USER WAS WEARING PROPER PPE AT THE TIME OF THE REPORTED EVENT. THE RAPICIDE PA PART A SDS PROVIDES THE FOLLOWING WARNING LANGUAGE AND GUIDANCE, RELATED TO SKIN EXPOSURE AND PPE USAGE: "CAUSES SEVERE SKIN BURNS AND EYE DAMAGE. WASH HANDS THOROUGHLY AFTER HANDLING. WEAR PROTECTIVE GLOVES/PROTECTIVE CLOTHING/EYE PROTECTION/FACE PROTECTION...IF ON SKIN (OR HAIR): RINSE SKIN WITH WATER/SHOWER." NO ADDITIONAL REPORTS OF ADVERSE EVENT OR HARM WERE RECEIVED. MEDIVATORS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS TO ENSURE THE PRODUCT CONTINUES TO PERFORM AS EXPECTED.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT RAPICIDE PA HIGH-LEVEL DISINFECTANT PART A SPLASHED ON AN EMPLOYEE'S FOREARM. THE EMPLOYEE EXPERIENCED REDNESS AND RAISING OF THE SKIN. THE EMPLOYEE WASHED THE AFFECTED AREA. THE EMPLOYEE WAS REPORTED TO BE WEARING GLOVES, BUT IT IS UNKNOWN IF OTHER PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS WORN AT THE TIME OF THE EXPOSURE. NO ADDITIONAL REPORTS OF INJURY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623228 RAPICIDE PA HIGH LEVEL DISINFECTANT HIGH LEVEL DISINFECTANT FEB MEDIVATORS INC ML02-0117 00677964090172

    Patients

    Seq Age Sex Outcome Treatment
    1