BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2232500 · Received September 2, 2011

    Report

    Report Number
    1525712-2011-00489
    Date Received
    September 2, 2011
    Report Date
    September 1, 2011
    Manufacturer
    KENSTONE METAL
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THE MODEL 65950 WITH LOT# KS102910 IS PROVIDED USER INSTRUCTIONS PART NUMBER 1160852 REV A (7/11). IT CONTAINS WARNINGS, CAUTIONS AND INSTRUCTIONS THAT IF FOLLOWED MAY HAVE PREVENTED THE ISSUE. IT IS UNKNOWN IF THE DEALER AND CONSUMER HAVE FULLY READ AND UNDERSTAND THE USER INSTRUCTIONS. PAGE 1 PROVIDES A WARNING FOR READING AND UNDERSTANDING THE USER INSTRUCTIONS. "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 A PHYSICIAN OR THERAPIST DETERMINED IF THIS IS THE CORRECT DEVICE FOR THE CONSUMER. PAGE 1 PROVIDES THE FOLLOWING WARNING. "EACH INDIVIDUAL SHOULD ALWAYS CONSULT WITH THEIR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE. A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE HEIGHT ADJUSTMENT OF THE KNEE WALKER FOR MAXIMUM SUPPORT." IT IS UNKNOWN IF THE DEALER AND CONSUMER CHECKS THE PARTS AND CASTERS BEFORE USE. PAGE 1 PROVIDES THE FOLLOWING WARNING. "CARE SHOULD BE TAKEN TO ENSURE THAT ALL PARTS OF THE KNEE WALKER ARE SECURE AND THE CASTERS ARE IN GOOD WORKING ORDER BEFORE USE." THE USAGE TECHNIQUE OF THE CONSUMER IS UNKNOWN. PAGE 1 PROVIDES THE FOLLOWING WARNING. "DO NOT SIT ON THE KNEE WALKER. DO NOT USE THE KNEE WALKER AS A WHEELCHAIR OR TRANSPORT DEVICE. DO NOT ATTEMPT TO REACH OBJECTS THAT ARE OUT OF YOUR IMMEDIATE REACH WHILE USING THIS DEVICE. DO NOT REACH FOR OBJECTS IF YOU HAVE TO LEAN OR SHIFT POSITION ON THE KNEE PAD." THE HEIGHT AND WEIGHT OF THE CONSUMER IS UNKNOWN. ALSO, IT IS UNKNOWN IF THE CONSUMER IS LOADING THE DEVICE. PAGE 1 PROVIDES THE FOLLOWING WARNINGS. "ALWAYS OBSERVE THE WEIGHT LIMIT ON THE LABELING OF YOUR PRODUCT. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY. DO NOT HANG ANYTHING FROM THE FRAME OF THE KNEE WALKER. ITEMS SHOULD BE PLACED IN THE BASKET. ITEMS SHOULD NOT PROTRUDE FROM THE KNEE WALKER BASKET - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE BASKET CAN HOLD UP TO 10 LBS. MODEL PATIENT HEIGHT MIN. / MAX - 65950 5' 2" - 5' 10". " IT IS UNKNOWN IF THERE ARE ACCESSORIES IN USE ON THE DEVICE. PAGE 1 PROVIDES THE FOLLOWING 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." THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN EFFECT CONSUMER STABILITY AND ARE UNKNOWN. A PRODUCT NOTE ON PAGE 2 STATES: "THE KNEE WALKER IS DESIGNED TO ENHANCE USER STABILITY." IT IS UNKNOWN IF THE CONSUMER FOLLOWS THE FOLLOWING CARE AND MAINTENANCE REQUIREMENTS FOUND ON PAGE 2. "PERIODICALLY INSPECT ALL PARTS OF THE KNEE WALKER FOR WEAR OR DAMAGE. REPLACE ANY BROKEN, WORN OR DAMAGED ITEMS IMMEDIATELY. VERIFY THE OPERATION OF THE BRAKES. CONTACT YOUR INVACARE DEALER FOR BRAKE ADJUSTMENT IF NECESSARY. IF HAND GRIPS ARE LOOSE, DO NOT USE THE KNEE WALKER. PERIODICALLY INSPECT THE CASTERS AND CASTER STEMS FOR TIGHTNESS. VERIFY THAT THE WHEELS ARE FREE OF HAIR, LINT AND OTHER DEBRIS."

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE 65960 KNEE ROLLATORS HAVE ALLEGEDLY BEEN FAILING ON HER. OUT OF THE PAST 8 WALKERS, 5 OF THEM HAVE FAILED. SHE INDICATED THAT FOUR OF THEM INVOLVED THE WHEELS ALLEGEDLY BREAKING. THE DEALER STATES THAT THEY ALWAYS EDUCATE THEIR PATIENTS ON PROPER USE, AND INSTEAD OF FOLLOWING THE 300 WEIGHT CAP, THEY ALWAYS STAY AT 250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP KENSTONE METAL 65950 KS102910

    Patients

    Seq Age Sex Outcome Treatment
    1 Other