BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PILL CRUSHER

    MDR report key: 3870189 · Received June 6, 2014

    Report

    Report Number
    MW5036537
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    HEALTH ENTERPRISES
    Product Code
    OHY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PILL CRUSHER USED TO CRUSH PROTONIX. CLEAR PLASTIC INSIDE PORTION BROKE DURING CRUSHING, RESULTING IN SHARDS OF PLASTIC BEING MIXED WITH PROTONIX. MEDICATION WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331475 PILL CRUSHER PILL CRUSHER OHY HEALTH ENTERPRISES PC1226 PC1226

    Patients

    Seq Age Sex Outcome Treatment
    1