BEUDAMED
    FDA Adverse Event Other Summary report: N

    EZ WAY INC.

    MDR report key: 589459 · Received March 30, 2005

    Report

    Report Number
    MW1035106
    Event Type
    Other
    Date Received
    March 30, 2005
    Date of Event
    November 3, 2004
    Report Date
    March 24, 2005
    Manufacturer
    EZ WAY
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS BEING LIFTED FROM FLOOR USING EZ LIFT WHEN CLEVIS AND "DROPPED" PT TO FLOOR, (APPROX 8") - IT WAS THEN REVEALED A PIN WAS INCORRECTLY INSTALLED AFTER A "CHANGE ORDER" AND THE PIN HAD NOT GONE THRU THE CLEVIS EYELET DOT ABOVE IT. PRESSURE FROM THE BOLT/PIN HAD HELD CLEVIS IN PLACE DURING SHOP TEST BUT WEIGHT OF PT OVERCAME THAT TENSION - RELEASING THE PT TO FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ WAY INC. EZ LIFT (PATIENT SLING) FSA EZ WAY EZ LIFT *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other