BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL DESIGN & MANUFACTURING

    MDR report key: 908716 · Received September 5, 2007

    Report

    Report Number
    MW5003642
    Event Type
    Injury
    Date Received
    September 5, 2007
    Date of Event
    August 2, 2007
    Report Date
    September 5, 2007
    Manufacturer
    DR. K HEALTHCARE PRODUCTS
    Product Code
    INB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD BEEN PLACED IN SHOWER CHAIR BY PATIENT CARE TECHNICIAN. UPON PROCEEDING TO SHOWER, PT LEANED FORWARD AND FELL FROM THE SHOWER CHAIR DUE TO INSTABILITY OF CHAIR LEGS. THE PT WAS HOSPITALIZED DUE TO A RIGHT HIP FRACTURE REPAIR. UPON FALLING FROM THE SHOWER CHAIR, THE PT SUSTAINED A FRACTURE TO THE LEFT HIP. DATES OF USE: APPROX EIGHT MONTHS IN 2007. DIAGNOSIS OR REASON FOR USE: ASSISTANCE TO PATIENTS WHO ARE UNABLE TO STAND FOR SHOWER. EVENT ABATED AFTER USE STOPPED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL DESIGN & MANUFACTURING DELUX HEAVY DUTY BATH BENCH INB DR. K HEALTHCARE PRODUCTS 12021 KDR-2

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| S