BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2245822 · Received September 13, 2011

    Report

    Report Number
    1525712-2011-00508
    Date Received
    September 13, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 12, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THE DEVICE. REPLACEMENT OF THE DEVICE HAS ORDERED. CONSUMERS OF MODEL 6291-5F SERIAL NUMBER (B)(4) WERE ISSUED OWNERS MANUAL PART NO 1148068. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTANDS THE OWNERS MANUAL. THE FOLLOWING WARNING IS PROVIDED ON PAGE 1: "WARNING - DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. . IT IS UNKNOWN IF THE CONSUMER ADHERED TO THE WARNINGS ON PAGE 1. THE FOLLOWING WARNINGS ARE PROVIDED AND IF FOLLOWED MAY HAVE MITIGATED THE CONSUMERS FALL. "YOU SHOULD ALWAYS CONSULT WITH YOUR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE." "ALWAYS USE CAUTION WHEN USING THE WALKER, ESPECIALLY ON WET OR ICY SURFACES." "IF THE WALKER IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS DO NOT TWIST ON SIDE FRAME OTHERWISE DAMAGE OR INJURY MAY OCCUR. THE HANDGRIPS MUST BE TIGHT." "ENSURE THAT THE RUBBER TIPS AND/OR PLASTIC GLIDE TIPS ARE NOT RIPPED, WORN OR MISSING. REPLACE THE TIPS AS NECESSARY BEFORE USING WALKER. DO NOT USE RUBBER TIPS ON REAR LEG EXTENSIONS WHEN USING WHEELS ON THE FRONT LEGS." "ALL LEG EXTENSIONS MUST BE ADJUSTED TO THE SAME HEIGHT SO THE WALKER IS LEVEL. WHEN USING WHEELED ATTACHMENTS ON THE FRONT LEGS, THE REAR LEG EXTENSIONS MUST BE ADJUSTED TO MAKE THE SIDE FRAMES LEVEL." "REAR EXTENSION LEGS WITH RUBBER TIPS OR PLASTIC GLIDE TIPS MUST BE IN CONTACT WITH FLOOR SURFACE AT ALL TIMES. IF AN EVEN HEIGHT CANNOT BE ACHIEVED, ADJUST THE LEG EXTENSIONS SO THAT THE REAR OF THE WALKER IS NO MORE THAN ONE INCH LOWER THAN THE FRONT." "GLIDE TIPS ARE USED ON REAR LEG EXTENSIONS ONLY TO ALLOW WALKER TO ROLL EASILY OVER INDOOR CARPETED AREAS WITHOUT LIFTING THE WALKER OFF THE GROUND. GLIDE TIPS ARE NOT RECOMMENDED FOR USE ON ROUGH SURFACES (CONCRETE, GRAVEL, ETC). "GLIDE TIPS ON REAR LEG EXTENSIONS SHOULD ONLY BE USED WITH FRONT WHEEL ATTACHMENTS. DO NOT USE GLIDE TIPS ON ALL FOUR LEG EXTENSIONS AT ONCE. DO NOT USE GLIDE TIPS AND RUBBER TIPS AT THE SAME TIME." "WHEN USING GLIDE TIPS ON WALKER, SHORT STEPS SHOULD BE TAKEN. MAKE SURE THAT THE PATIENT'S WEIGHT IS DISTRIBUTED EVENLY AND DIRECTLY OVER THE WALKER LEGS. THESE PRECAUTIONS WILL PREVENT UNCONTROLLABLE MOVEMENT OF WALKER." "ALWAYS OBSERVE THE WEIGHT LIMIT ON THE LABELING OF YOUR WALKER. THE WALKER IS NOT INTENDED TO SUPPORT THE FULL WEIGHT OF THE USER. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY." "AFTER UNFOLDING OR ASSEMBLING WALKER, MAKE SURE THE WALKER IS SECURELY LOCKED IN THE OPEN POSITION AND LEVEL TO THE GROUND BEFORE USING." "DO NOT HANG ANYTHING OTHER THAN THE MANUFACTURER'S RECOMMENDED ACCESSORIES ON THE FRONT OF THE WALKER. THIS MAY DEPRESS THE RELEASE MECHANISMS AND PREVENT WALKER FROM LOCKING INTO PLACE WHEN FULLY OPENED. DO NOT USE A WALKER IF THE LOCKING MECHANISMS DO NOT FUNCTION PROPERLY." "DO NOT HANG ANYTHING ON EITHER THE LEFT OR RIGHT SIDE FRAMES (AREA THAT INCLUDES DUAL-RELEASE PADDLES) OR THE LEFT AND RIGHT SLIDE TUBES (AREA THAT INCLUDES PALM RELEASE BUTTON). THIS WILL CAUSE SIDE FRAMES OR SLIDE TUBES TO BEND AND PREVENT THE WALKER FROM LOCKING WHEN FULLY OPENED. THIS MAY ALSO CAUSE WALKER TO TIP, RESULTING IN INJURY OR DAMAGE." "WHEELED ACCESSORIES ARE ONLY TO BE USED ON THE FRONT WALKER LEGS WITH THE EXCEPTION OF MODEL NOS. 6264 - 10-INCH REAR WHEEL BRAKES AND 6265 - 13-INCH REAR WHEEL BRAKES." "ALWAYS TEST TO SEE THAT THE WALKER AND ATTACHMENTS ARE PROPERLY AND SECURELY LOCKED IN PLACE BEFORE USING."

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE PLAY IN THE RIGHT SIDE CAUSED HIM TO TRIP. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP GENTEEL (MAXHEALTH) 6291-5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other