BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LEFT

    MDR report key: 633283 · Received September 1, 2005

    Report

    Report Number
    2182305-2005-00029
    Event Type
    Other
    Date Received
    September 1, 2005
    Date of Event
    July 27, 2005
    Report Date
    August 29, 2005
    Manufacturer
    APEX HEALTHCARE MFG., INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY DEALER AMERICAN HOMECARE SUPPLY, PER DEALER THE HYDRAULIC JACK BROKE BOLT AT BOTTOM OF JACK CAME OUT, LOOKED AS THOUGH IT UNSCREWED ITSELF. DEALER REPLACED THE JACK AND RETURNED TO END USER HOME IN 08/2005 THEN SHIPPED BACK FAILED JACK TO MANUFACTURER. PATIENT SENT TO HOSPITAL ER FOR EVALUATION BRUISING EVIDENT, LENGTH OF STAY UNKNOWN, PATIENT IS BACK HOME NOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other