BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2251769 · Received September 16, 2011

    Report

    Report Number
    1525712-2011-00522
    Date Received
    September 16, 2011
    Report Date
    September 16, 2011
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS SHOWER CHAIR. THE MODEL IS 9781 AND SERIAL NUMBER/LOT CODE IS UNKNOWN. THE USER INSTRUCTIONS FOR THIS DEVICE IS USER MANUAL PART NO 1122173. THE LATEST REVISION [REV C 01/09] WAS USED FOR THIS DOCUMENTATION. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER INSTRUCTIONS PRIOR TO USING THE DEVICE. THE FOLLOWING WARNING IS PROVIDED. "DO NOT INSTALL OR USE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS INSTRUCTION SHEET. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL, BEFORE ATTEMPTING TO INSTALL THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR." THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN OF THE CONSUMER IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER WAS LEANING REACHING OR BENDING AT THE TIME OF THE INCIDENT. THE FOLLOWING WARNINGS ARE PROVIDED FOR STABILITY OF THE SHOWER CHAIR. " ALL FOUR LEG TIPS MUST BE IN CONTACT WITH SHOWER/TUB FLOOR AT ALL TIMES." "ALWAYS INSPECT THE SHOWER CHAIR TO ENSURE THAT IT IS PROPERLY POSITIONED AND STABLE BEFORE USING. DO NOT USE THE SHOWER CHAIR IF IT IS WOBBLY OR UNSTABLE." "THE SHOWER CHAIR LEGS HAVE SUCTION FEET. CHECK THE SUCTION FEET FOR RIPS, TEARS, CRACKS OR WEAR. IF ANY OF THESE CONDITIONS EXIST, REPLACE THEM IMMEDIATELY." "USERS WITH LIMITED PHYSICAL CAPABILITIES SHOULD BE SUPERVISED OR ASSISTED WHEN USING THE SHOWER CHAIR." "ENSURE THAT THE SHOWER CHAIR IS LEVEL AND STABLE BEFORE USE." "USERS WITH LIMITED PHYSICAL CAPABILITIES SHOULD BE SUPERVISED OR ASSISTED WHEN USING THE SHOWER CHAIR." THE SIZE OF THE TUB IS UNKNOWN. THE FOLLOWING WARNING IS PROVIDED. "THIS PRODUCT SHOULD ONLY BE USED WITH TUB FLOORS WIDER THAN 16-INCHES." THE CONSUMERS TECHNIQUE USING THE DEVICE IS UNKNOWN. THE FOLLOWING WARNING IS PROVIDED. "THE SHOWER CHAIR IS NOT TO BE USED AS A TRANSFER BENCH, TRANSFER DEVICE OR CLIMBING DEVICE." THE CONSUMERS WEIGHT IS UNKNOWN. IT IS UNKNOWN IF ADDITIONAL LOADING WAS APPLIED TO THE DEVICE. "THESE SHOWER CHAIRS (MODELS 9780 AND 9781) HAVE A WEIGHT LIMITATION OF 400 LB (182 KG) EACH." IT IS UNKNOWN IF THE DEVICE WAS SET UP PROPERLY. IF THE COMPRESSION BUTTONS ARE NOT SECURED PROPERLY THEN THE SHOWER CHAIR MAY BECOME UNSTABLE AND CAUSE A LEG TO SNAP UPON LOADING OF THE CHAIR. THE FOLLOWING WARNINGS ARE PROVIDED. "EXERCISE CAUTION WHEN ASSEMBLING THE SHOWER CHAIR TO AVOID PINCHING." "FOR SHOWER CHAIR MODEL 9781 - ENSURE THAT THE COMPRESSION BUTTONS ON THE BACKREST ARE FULLY VISIBLE THROUGH THE NOTCH ON THE BACK."

    Description of Event or Problem · 1

    THE LEGS ALLEGEDLY "GAVE WAY" ON THIS SHOWER CHAIR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX POPULAR PLASTICS 9781 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other