BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2193148 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00424
    Date Received
    August 5, 2011
    Date of Event
    October 1, 2010
    Report Date
    August 4, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL AND SERIAL NUMBER OF THE WALKER INVOLVED IN THE EVENT ARE UNKNOWN. THERE HAS BEEN NO RMA FOR THE RETURN OF THE DEVICE ISSUED AS OF THIS MDR SUBMISSION. THE CONSUMER IS A (B)(6) FEMALE WHO STANDS (B)(6) TALL AND (B)(6). SHE USES THE WALKER DUE TO HER ARTHRITIS CONDITION. ACCORDING TO THE CONSUMER, THE LEG PUNCTURE WAS FROM THE "INNER HANDLES." THE INNER HANDLES ARE REFERENCING THE COMMON INVACARE NAME, "PADDLES." PADDLES ARE USED AS THE LOCK/RELEASE MECHANISM FOR FOLDING/UNFOLDING THE WALKER. THERE ARE SEVERAL TYPES OF PADDLES ON WALKERS AND THE TYPE ON DEVICE INVOLVED IS UNKNOWN. THE CONDITION OF THE PADDLES IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER WAS SITTING, STANDING OR GETTING INTO OR OUT OF A SEAT AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE DEVICE WAS FOLDED OR UNFOLDED. LOADING OF THE DEVICE IS UNKNOWN. THE STABILITY OF THE CONSUMER USING THE DEVICE IS UNKNOWN. THE CONSUMER'S MEDICATION REGIMEN IS UNKNOWN. INVACARE PROVIDES ALL CONSUMERS OF WALKERS USER INSTRUCTIONS AT THE TIME OF PURCHASE. IT IS UNKNOWN IF THE CONSUMER READ AND FULLY UNDERSTOOD THE USER INSTRUCTIONS PRIOR TO USING THE DEVICE. THE USER INSTRUCTIONS PROVIDE THE FOLLOWING WARNINGS THAT MAY RELATE TO THIS EVENT:. "YOU SHOULD ALWAYS CONSULT WITH YOUR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE." "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. 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

    WHILE AT THE DOCTOR'S OFFICE, THE CONSUMER ALLEGES THE INNER HANDLES OF THE WALKER ATTACHMENT PUNCTURED HER LEG. THE CONSUMER'S WOUND WAS CLEANED AND BANDAGED ON SITE. THE WOUND ALLEGEDLY CONTINUED TO OPEN AND WOULD NOT HEAL. THE CONSUMER HAS ALLEGEDLY HAD WOUND TREATMENTS AT A WOUND CLINIC FOR THE LAST 5 MONTHS. MOST RECENTLY, THE CONSUMER ALLEGEDLY SPENT 9 DAYS IN THE HOSPITAL FOR IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79