BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.M ADAMS CO, INC.

    MDR report key: 11055183 · Received December 22, 2020

    Report

    Report Number
    11055183
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 24, 2020
    Manufacturer
    E.M. ADAMS, INC.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RESTRAINED TO THE BED FRAME, AND STARTED TO BECOME AGITATED WHEN HE RAISED HIS ARMS AND THE RESTRAINT LIMB HOLDER CUFF TORE FROM THE NYLON STRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518070 E.M ADAMS CO, INC. RESTRAINT, PROTECTIVE FMQ E.M. ADAMS, INC. 26-0647-1 HN 09-20

    Patients

    Seq Age Sex Outcome Treatment
    1