BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2244016 · Received September 12, 2011

    Report

    Report Number
    1525712-2011-00504
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    September 12, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. CONSUMERS OF MODEL 6291-JR ARE PROVIDED OWNERS MANUAL PN - PART NO 1148068 REV F (2/09) FOR REVIEW. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTANDS THE OWNERS MANUAL. THE FOLLOWING WARNING IS PROVIDED: "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 UNDERSTOOD THE FOLLOWING WARNINGS PROVIDED IN THE OWNERS MANUAL. FOLLOWING THESE WARNINGS MAY HAVE PREVENTED THE ISSUE. "EACH INDIVIDUAL SHOULD ALWAYS CONSULT WITH THEIR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE. DO NOT USE THE ROLLATOR AS A WHEELCHAIR OR TRANSPORT DEVICE. ROLLATORS ARE NOT INTENDED TO BE PROPELLED WHILE SEATED. THE BRAKES MUST BE IN THE LOCKED POSITION BEFORE USING THE SEAT. A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE HEIGHT ADJUSTMENT OF THE ROLLATOR FOR MAXIMUM SUPPORT AND CORRECT BRAKE ACTIVATION. CARE SHOULD BE TAKEN TO ENSURE THAT ALL HAND AND HEIGHT ADJUSTMENTS ARE SECURE, AND THAT CASTERS AND MOVING OBJECTS ARE IN GOOD WORKING ORDER BEFORE USING THIS OR ANY MOBILITY AID. ALL WHEELS MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES DURING USE. THIS WILL ENSURE THE ROLLATOR IS PROPERLY BALANCED. WHEN USING THE ROLLATOR IN A STATIONARY POSITION, THE HAND BRAKES MUST BE LOCKED. ALWAYS OBSERVE THE WEIGHT LIMIT ON THE LABELING OF YOUR PRODUCT. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY. THE ROLLATOR BASKET HAS A WEIGHT LIMITATION OF 11 LBS (5 KG). THE TOTE BAG HAS A WEIGHT LIMITATION OF 10 LBS (5 KG). ITEMS PLACED IN EITHER THE BASKET OR THE BAG SHOULD NOT PROTRUDE FROM THE BASKET OR BAG. IF PUSH HANDLES ARE EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HAND GRIPS DO NOT TWIST ON ROLLATOR HANDLE - OTHERWISE DAMAGE OR INJURY MAY OCCUR. AFTER INSTALLATION AND BEFORE USE, ENSURE THAT ALL ATTACHING HARDWARE IS TIGHTENED SECURELY. DO NOT ATTEMPT TO REACH OBJECTS IF YOU HAVE TO MOVE FORWARD IN THE SEAT. REACHING FOR THESE OBJECTS WILL CAUSE A CHANGE TO THE WEIGHT DISTRIBUTION OF THE ROLLATOR AND MAY CAUSE THE ROLLATOR TO TIP, RESULTING IN INJURY OR DAMAGE. DO NOT HANG ANYTHING FROM THE FRAME OF THE ROLLATOR. ITEMS SHOULD BE PLACED IN THE BASKET OR THE TOTE BAG. THE BACKREST SHOULD ALWAYS BE IN PLACE AND IS NOT DESIGNED TO SUPPORT THE TOTAL BODY WEIGHT OF THE USER. BEFORE ATTEMPTING TO REACH OBJECTS OR PICK THEM UP FROM THE FLOOR BY REACHING DOWN BETWEEN YOUR KNEES, PLACE FEET SECURELY ON THE FLOOR. USE EXTREME CAUTION WHEN REACHING FOR ANY OBJECT." THE MAINTENANCE HISTORY OF THIS DEVICE IS UNKNOWN. FOLLOWING THE CARE AND MAINTENANCE REQUIREMENTS OF THE DEVICE MAY HAVE PREVENTED THE ISSUE. "CARE AND MAINTENANCE MAKE SURE THAT ALL ATTACHING HARDWARE IS IN PLACE AND SECURE AT ALL TIMES. REPLACE ALL BROKEN, DAMAGED OR WORN ITEMS IMMEDIATELY. MAKE SURE THAT THE LOCKING MECHANISMS FUNCTION PROPERLY. LUBRICATE WITH 3-IN-1 OIL AS NECESSARY OR IF WHEELS BEGIN TO SQUEAK."

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES HIS HEEL WAS CUT ON THE SCREW AND NUT ON THE INSIDE OF THE WALKER THAT SECURES THE FIXED WHEEL. THE CONSUMER WENT TO THE HOSPITAL AND WAS RELEASED THE SAME DAY. NO SERIOUS 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-JR

    Patients

    Seq Age Sex Outcome Treatment
    1 88 Other