BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE SOFT HANDGUARD MITT

    MDR report key: 18579142 · Received January 25, 2024

    Report

    Report Number
    18579142
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    September 12, 2023
    Report Date
    September 13, 2023
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CONFUSED, APPEARS THAT HE WAS ABLE TO POKE HIS FINGER THROUGH THE GREEN CLOTH ON THE MITTENS, WHICH RESULTED IN THE SMALL BEAD MATERIAL STUFFING CONTENTS OF THE MITTS TO GO ALL OVER THE PATIENT'S TORSO AND THE BED. BEADS WERE VERY DIFFICULT TO COLLECT AND COULD EASILY BE INHALED. PATIENT NOTED TO HAVE SHORT NAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190594 MEDICHOICE SOFT HANDGUARD MITT RESTRAINT, PROTECTIVE FMQ OWENS & MINOR DISTRIBUTION, INC. MTT2810

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA Male