BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEY LOCK BELT

    MDR report key: 2478465 · Received February 16, 2012

    Report

    Report Number
    2020362-2012-00074
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    January 15, 2012
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    FMQ
    PMA / PMN Number
    K964157
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT WAS DISCARDED BY THE CUSTOMER AND THERE WAS NO LOT/MFG DATE RECORDED. (B)(4).

    Description of Event or Problem · 1

    THE NURSE REPORTED THAT THEY HEARD A NOISE FROM THE PT'S ROOM AND FOUND THE PT SITTING ON THE FLOOR NEXT TO THEIR CHAIR WITH THE WAIST RESTRAINT UNDONE. THE NURSE THOUGHT THE LOCKING BUCKLE WAS LOCKED BUT IT HAD NOT FULLY ENGAGED. THE NURSE ALSO STATED THAT THEY HAD DIFFICULTY IN CLOSING THE LOCK. THE NURSE STATED THE PT REPORTED THAT THEY JUST LOST THEIR BALANCE AND DENIED ANY PAIN OR INJURY. THE PT STOOD WITH MINIMAL ASSISTANCE BACK TO THEIR CHAIR. THE NURSE REPORTED THAT THEIR LAUNDRY SERVICE IS PERFORMED OFF-SITE BUT COULDN'T PROVIDE THE SPECIFICS OF HOW THE PRODUCT WAS LAUNDERED. THE RESTRAINT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEY LOCK BELT FMQ J. T. POSEY COMPANY 1334 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI