BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEALTHSMART PILL CRUSHER

    MDR report key: 10479652 · Received September 1, 2020

    Report

    Report Number
    0002183416-2020-00004
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Report Date
    September 1, 2020
    Manufacturer
    APOTHECARY PRODUCTS LLC.
    Product Code
    OHY
    UDI-DI
    00079573009161
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APOTHECARY PRODUCTS LLC. RECEIVED A REPORT FROM MEDWATCH (REPORT NUMBER MW5095448 [MDR REPORT KEY (B)(4)]) : WHEN SPEAKING WITH A GROUP OF NURSING STAFF ABOUT OUR CURRENT PRACTICES OF CRUSHING MEDICATION TABLETS, IN RESPONSE TO AN (B)(4) NEWSLETTER ABOUT AN ISSUE WITH A PLASTIC ENTERAL SYRINGE PRODUCT, IT WAS BROUGHT TO MY ATTENTION AN ISSUE WITH A DIFFERENT PRODUCT WE USE FOR PILL CRUSHING. CURRENTLY, A PRODUCT WE CARRY IS THE HEALTHSMART PILL CRUSHER/PULVERIZER. SEVERAL NURSES HAVE BROUGHT IT TO MY ATTENTION THAT IN THE PAST, WHEN USING THE PRODUCT TO CRUSH TABLETS, THE PLASTIC BOTTOM HAS SHATTERED/BROKEN WHILE IN USE. THIS COULD HAVE LED TO SMALL PIECES OF PLASTIC BEING ADMINISTERED TO PATIENTS IF NURSING STAFF WAS NOT CAREFUL. WE ARE CURRENTLY IN THE PROCESS OF REMOVING THESE PRODUCTS FROM ALL OF OUR UNITS TO PREVENT ANY BREAKAGES IN THE FUTURE. WE WILL INSTEAD UTILIZE OUR OTHER PRODUCT, SILENT KNIGHT, IN THE FUTURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945052 HEALTHSMART PILL CRUSHER PILL CRUSHER OHY APOTHECARY PRODUCTS LLC. PC12 00079573009161

    Patients

    Seq Age Sex Outcome Treatment
    1