BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYER LIFTER

    MDR report key: 2123415 · Received November 3, 2008

    Report

    Report Number
    2182305-2008-00038
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 5, 2008
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FNG
    Removal / Correction Number
    RECALL #Z-1135-2008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DISTRIBUTOR, BY FACILITY, (B)(6), PER FACILITY THIS SCALE/CRADLE COMBINATION WAS AFFECTED BY BHM RECALL AND PER FACILITY, THEY DID RECEIVE RECALL INFORMATION ON SAID LIFT AS WELL AS THE FIELD REPAIR KIT; WHICH THE CORRECTION ACTION WAS COMPLETED BY THEM ON (B)(6) 2008. FACILITY STATED INCIDENT HAPPENED ON (B)(6), PER FACILITY, THEY WERE IN THE PROCESS OF TRANSFERRING A RESIDENT FROM WHEEL CHAIR TO STRETCHER; TWO C.N.A.'S WERE PRESENT WHEN THE SPREADER BAR FELL FROM THE SCALE AND RESIDENT FELL TO THE FLOOR. RESIDENT WAS SENT TO THE HOSPITAL BY AMBULANCE, X-RAYS TAKEN SHOWED FRACTURE TO THE COCCYX. RMA #84001370 ISSUED TO GET SCALE AND CRADLE BACK FOR EVALUATION. REPLACEMENT ORDER (B)(4). BHM MANUFACTURER OF LIFT HAS BEEN NOTIFIED. BHM RECALL NUMBER IS AS FOLLOWS: Z-1135-2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFTER PATIENT LIFTER FNG BHM MEDICAL INC. HPL600WBSC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization