BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 620384 · Received July 7, 2005

    Report

    Report Number
    2182305-2005-00014
    Event Type
    Other
    Date Received
    July 7, 2005
    Date of Event
    June 19, 2005
    Report Date
    July 5, 2005
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY END USER THAT THEY HAD PURCHASED THIS POOL LIFT LAST FEBRUARY FROM AN ON LINE DEALER AND USED IT FOR THE FIRS TIME LAST WEEK. PER SPOUSE, THEY MOVED LIFT FROM THE SPA AREA TO THE POOL AREA, WAS LIFTING PT FROM THE POOL WHEN THE CHAIN POPPED OUT OF THE S HOOK NEAR THE BOTTOM OF THE SLING AND THREW PT BACK INTO THE POOL. AFTER FURTHER CONVERSATION WITH SPOUSE, THEY STATED IT WAS THE LARGER S HOOK THAT CONNECTS THE ONE LONG CHAIN INTO THE TWO SHORTER CHAINS THAT BROKE. PATIENT WAS HAVING TROUBLE WITH THEIR LEFT ANKLE AND BRUISING TO BOTH ARMS BECAUSE THEY WERE HOLDING ON TO THE CHAINS. WENT TO THE DOCTOR, ANKLE STILL SORE AND SWOLLEN, END USER STATED THIS WAS VERY SCARY FOR PT. SENDING OUT REPLACEMENT CHAINS FOR END USER UNDER RMA #616417. WILL BE GETTING BROKEN PIECE BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FSA APEX HEALTH CARE MFG., INC. SS-HSP *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other