BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT KNIGHT SLEEVES

    MDR report key: 15470270 · Received September 23, 2022

    Report

    Report Number
    15470270
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 14, 2022
    Manufacturer
    LINKS MEDICAL PRODUCTS INC
    Product Code
    OHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SEAL NOT INTACT IN A CORNER ALLOWING MEDICATIONS TO FALL THROUGH POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554464 SILENT KNIGHT SLEEVES PILL CRUSHER/CUTTER OHY LINKS MEDICAL PRODUCTS INC PC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown