BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2220510 · Received August 23, 2011

    Report

    Report Number
    1525712-2011-00454
    Date Received
    August 23, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 23, 2011
    Manufacturer
    POPULAR PLASTICS
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 FOLLOWING WARNINGS ARE PROVIDED TO THE CONSUMER PRIOR TO USING THE DEVICE. IT IS UNKNOWN IF THE CONSUMER READ AND UNDERSTOOD THE INSTRUCTION SHEET PART NO 1122173 PAGE 1. "PAGE 1 WARNING: 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." IT IS UNKNOWN IF THE SHOWER CHAIR WAS LEVEL AND STABLE AT THE TIME OF THIS EVENT. "PAGE 1 WARNING: 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 CONDITION OF THE SUCTION FEET IS UNKNOWN. "PAGE 1 WARNING: 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." THE SIZE OF THE TUB IS UNKNOWN. "PAGE 1 WARNING: THIS PRODUCT SHOULD ONLY BE USED WITH TUB FLOORS WIDER THAN 16-INCHES." IT IS UNKNOWN IF THE CONSUMER WAS BEING ASSISTED. "PAGE 1 WARNING: USERS WITH LIMITED PHYSICAL CAPABILITIES SHOULD BE SUPERVISED OR ASSISTED WHEN USING THE SHOWER CHAIR. THE SHOWER CHAIR IS NOT TO BE USED AS A TRANSFER BENCH, TRANSFER DEVICE OR CLIMBING DEVICE." THE WEIGHT OF THE CONSUMER WAS (B)(6) AND MET THE WEIGHT LIMITATIONS FOUND ON: "PAGE 1. THESE SHOWER CHAIRS (MODELS 9780 AND 9781) HAVE A WEIGHT LIMITATION OF 400 LB (182 KG) EACH." IT IS UNKNOWN IF THE CONSUMER WAS AFFECTED BY PINCH POINTS OR IF THE BACK REST WAS INVOLVED IN THIS ISSUE. 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 OF THE SEAT IT IS UNKNOWN IF THE CONSUMER IS USING CORRECT ACCESSORIES OR WAS OVERLOADING THE DEVICE. "PAGE 1 - ACCESSORIES WARNING: INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS." IT IS UNKNOWN IF THE CONSUMER FOLLOWS THE INSTALLATION WARNING BELOW. PAGE 1 - INSTALLATION WARNING: AFTER ANY ADJUSTMENTS, REPAIR OR SERVICE AND BEFORE USE, MAKE SURE THAT ALL PARTS ARE PROPERLY INSTALLED AND SECURE." IT IS UNKNOWN IF THE CONSUMER IS FOLLOWING THE CAUTION FOR THE SUCTION FEET. PAGE 1 CAUTION: THE SHOWER CHAIR LEGS HAVE SUCTION FEET. TO REMOVE SUCTION, CAREFULLY PULL UP ON THE LIP OF THE SUCTION FOOT TO RELEASE IT FROM THE TUB. IF THE SUCTION FEET ARE DAMAGED, THEY MUST BE REPLACED IMMEDIATELY. IT IS UNKNOWN IF THE SHOWER CHAIR WAS LEVEL AND STABLE AT THE TIME OF THE ISSUE. PAGE 1 - WARNING: ENSURE THAT THE SHOWER CHAIR IS LEVEL AND STABLE BEFORE USE.

    Description of Event or Problem · 1

    THE SEAT ALLEGEDLY CRACKED WHEN THE CONSUMER WAS IN THE SHOWER, CAUSING HIM TO FALL. 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 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other