BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATURE MART PILL SPLITTER

    MDR report key: 274835 · Received March 28, 2000

    Report

    Report Number
    MW4002745
    Event Type
    Malfunction
    Date Received
    March 28, 2000
    Date of Event
    February 1, 2000
    Report Date
    March 21, 2000
    Manufacturer
    DURO-MED INDUSTRIES, INC.
    Product Code
    OHY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PILL SPLITTER IS USED TO CUT TABLETS IN HALF FOR ACCURACY. HOWEVER, ACCORDING TO RPTR, THE PILL SPLITTER FROM MATURE MART NEEDS TO BE RECALLED BECAUSE THE CUTTING BLADE IS MISALIGNED AND IS GIVING AN INACCURATE SPLIT OF TABLETS. THIS MAY CAUSE SERIOUS CONSEQUENCES. THE MFR WAS CONTACTED AND THE PROBLEM WAS EXPLAINED. THE REPRESENTATIVE REPLIED "SO WHAT DO YOU WANT ME TO DO?".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATURE MART PILL SPLITTER PILL SPLITTER OHY DURO-MED INDUSTRIES, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO