BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACECIDE-C

    MDR report key: 20802566 · Received November 27, 2024

    Report

    Report Number
    3005763425-2024-00001
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    November 11, 2024
    Report Date
    November 27, 2024
    Manufacturer
    BEST SANITIZERS, INC.
    Product Code
    MED
    UDI-DI
    10359900300008
    PMA / PMN Number
    K091210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE STAFF WAS CHANGING THE LIQUID CHEMICALS IN THE OER-PRO MACHINE. THE BOTTOM OF THE BOTTLE WOULD NOT FIT INTO THE TRAY. THE STAFF MEMBER TOOK A SYRINGE AND PUNCTURED THE BOTTLE TO RELIEVE PRESSURE AND CAUSE THE BOTTLE TO DEFLATE. THE BOTTLE "EXPLODED" ONTO THE FACE AND ARMS OF THE STAFF MEMBER. THE STAFF WAS NOT WEARING PPE AND SUSTAINED A CHEMICAL BURN. USED THE EYEWASH STATION FOR TEN MINUTES AND YES EYES WERE STILL IRRITATED AND SAW WHITE SPOTS. THE STAFF MEMBER WAS TREATED AT THE HOSPITAL THE DAY OF THE EVENT AND HAVE HAD SEVERAL TRIPS TO THE EYE DOCTOR. NO SUSTAINED DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611537 ACECIDE-C MEDICAL DEVICE STERILANT MED BEST SANITIZERS, INC. 10359900300008

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention| O