BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFTER

    MDR report key: 730344 · Received June 26, 2006

    Report

    Report Number
    2182305-2006-00024
    Event Type
    Other
    Date Received
    June 26, 2006
    Date of Event
    January 27, 2006
    Report Date
    June 12, 2006
    Manufacturer
    APEX HEALTHCARE MFG INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR WHILE DISCUSSING THE HYD JACK RECALL (Z0904-06) JACK CORRECTION ACTION PLAN WITH DEALER, CAROLINA APOTHECARY, DEALER MENTIONED THERE HAD BEENJ AND INCIDENT. DEALER STATED THAT AN END USER WHILE USING THE LIFT FELL, HER FALL RESULTED IN A FX LEG AND A CUT ABOVE HER EYE. WAS HOSPITALIZED FOR A TIME AND NOW IS HOME. END USER LIFT WAS SWITCHED OUT BY DEALER AND WERE RE-INSTRUCTED ON USE OF THE EQUIPMENT. MFR ISSUED RMA #674978 (LINE #21) TO GET JACK BACK FOR EVALUATION. LINES 1-20- OF THIS RMA ARE NEW REPLACEMENT JACK TO DEALER FOR THE REPLACEMENT PROGRAM. SERIAL NUMBER OF JACK COMPLAINT RECEIVED IS 0407L0745, MFG DATE OF JULY 2004. MFR DID C/A #CT041003 FOR FIX, THIS FIX WAS ISSUED AND IMPLEMENTAL DECEMBER 2004..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFTER PT LIFTER FSA APEX HEALTHCARE MFG INC C-HLA *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O