BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2193159 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00425
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 14, 2011
    Report Date
    August 5, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER IS A (B)(6) FEMALE WHO IS (B)(6) AND WEIGHS (B)(6). IT IS NOT KNOWN HOW LONG THE CONSUMER HAS BEEN USING THE DEVICE. IT IS NOT KNOWN IF THE CONSUMER READ AND FULLY UNDERSTANDS THE USER INSTRUCTIONS THAT WERE PROVIDED WITH THE DEVICE. IT IS UNKNOWN IF THE DEVICE WAS SET UP BY A PROFESSIONAL. IT IS UNKNOWN IF THE DEVICE WAS PROPERLY BALANCED. IT IS UNKNOWN IF THE HAND AND HEIGHT ADJUSTMENT WERE CORRECT. IT IS UNKNOWN IF ALL 4 WHEELS WERE ON THE GROUND AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE CONSUMER WAS TRYING TO SIT DOWN AND THE BRAKES WERE PROPERLY LOCKED. IT IS UNKNOWN IF THE CONSUMER WAS TRYING TO USE THE DEVICE AS A WHEELCHAIR. IT IS UNKNOWN IF THE CONSUMER WAS FOLLOWING THE WEIGHT LIMITATIONS FOR THE DEVICE OR IF THERE WAS EXCESSIVE LOADING TO THE DEVICE. THE FOLLOWING WARNING ARE GIVEN TO THE CONSUMER TO FOLLOW DURING USAGE OF THE DEVICE. PN 1076166 - PAGE 1 GENERAL WARNINGS: "DO NOT INSTALL THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS INSTRUCTION SHEET. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS AND INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL IF APPLICABLE BEFORE ATTEMPTING TO INSTALL THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR." "A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE PLACEMENT AND POSITIONING OF THE HAND GRIPS FOR MAXIMUM SUPPORT AND CORRECT BRAKE ACTIVATION. " "BE SURE THE ROLLATOR IS PROPERLY BALANCED BEFORE USING." "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." "ON MODEL 65420, THE BRAKES MUST BE IN THE LOCKED POSITION BEFORE USING THE SEAT." "THE ROLLATOR IS NOT INTENDED FOR PROPELLING WHILE SEATED. IT IS NOT TO BE PUSHED AND/OR USED AS A WHEELCHAIR." "THE ROLLATOR IS DESIGNED TO PROVIDE SUPPORT, INCREASED STABILITY AND ASSISTANCE TO THE END USER WHILE WALKING." "THE 3-WHEEL ROLLATOR IS NOT DESIGNED TO SUPPORT THE TOTAL WEIGHT OF AN INDIVIDUAL AND HAS A WEIGHT LIMITATION OF 250 LBS. (114KG.). " "THE 4-WHEEL ROLLATOR CAN PROVIDE AMBULATORY ASSISTANCE FOR AN INDIVIDUAL WEIGHING UP TO 270 LBS. (123KG.), INCLUDING THE WEIGHT OF THE CONTENTS OF THE BASKET AND TRAY. " "THE SEAT ON MODEL 65420 CAN SUPPORT AN INDIVIDUAL WEIGHING UP TO 270 LBS. (123 KG.)." "THE ROLLATOR BASKET HAS A WEIGHT LIMIT OF 15 LBS. (6 KG.). THE ROLLATOR TRAY HAS A WEIGHT LIMIT OF 5 LBS. (4.5 KG.)."

    Description of Event or Problem · 1

    THE CONSUMER WAS IN THE KITCHEN USING THE ROLLATOR WHEN THE WHEEL ALLEGEDLY GAVE IN, CAUSING THE UNIT TO COLLAPSE AND THE CONSUMER FELL TO THE FLOOR. 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 UNKNOWN 65420

    Patients

    Seq Age Sex Outcome Treatment
    1 59