BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2233877 · Received September 6, 2011

    Report

    Report Number
    1525712-2011-00494
    Date Received
    September 6, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 2, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THE MODEL AND SERIAL NUMBER ARE UNKNOWN. INVACARE PROVIDES A USER MANUAL CONTAINING WARNINGS, CAUTIONS AND INSTRUCTIONS FRO USE. ROLLATOR USER INSTRUCTIONS PART NO 1148077 WILL BE REFERENCED FOR THIS DOCUMENTATION. ON PAGE 1 THE FOLLOWING WARNING IS PROVIDED FOR THE CONSUMER TO FULLY READ AND UNDERSTAND THE USER INSTRUCTIONS PRIOR TO USE OF THE ROLLATOR. IT STATES - "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 ROLLATOR WAS PROPERLY ADJUSTED. WARNING- "EACH INDIVIDUAL SHOULD ALWAYS CONSULT WITH THEIR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE." IT IS UNKNOWN IF THE CONSUMER WAS TRYING TO SELF PROPEL THE DEVICE AT THE KITCHEN SINK. WARNING - "DO NOT USE THE ROLLATOR AS A WHEELCHAIR OR TRANSPORT DEVICE. ROLLATORS ARE NOT INTENDED TO BE PROPELLED WHILE SEATED." WEIGHT LIMITATIONS AND WARNINGS PROVIDED. ROLLATORS HAVE HEIGHT LIMITS. THE MODEL IS UNKNOWN. THE CONSUMER IS (B)(6). ROLLATORS HAVE WEIGHT LIMITS. THE MODEL IS UNKNOWN. THE CONSUMER WEIGHTS (B)(6). "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." "DO NOT HANG ANYTHING FROM THE FRAME OF THE ROLLATOR. ITEMS SHOULD BE PLACED IN THE BASKET OR THE TOTE BAG." IT IS UNKNOWN IF THE CONSUMER LOCKED THE BREAKS. WARNING - "THE BRAKES MUST BE IN THE LOCKED POSITION BEFORE USING THE SEAT." "WHEN USING THE ROLLATOR IN A STATIONARY POSITION, THE HAND BRAKES MUST BE LOCKED." IT IS UNKNOWN OF THE WHEELS WERE MAKING CONTACT WITH THE FLOOR AT THE TIME OF THE INCIDENT. WARNING - "ALL WHEELS MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES DURING USE. THIS WILL ENSURE THE ROLLATOR IS PROPERLY BALANCED." IT IS UNKNOWN IF THE CONSUMER ENSURES THE HARDWARE IS SECURELY TIGHTENED. WARNING - "AFTER INSTALLATION AND BEFORE USE, ENSURE THAT ALL ATTACHING HARDWARE IS TIGHTENED SECURELY." IT IS UNKNOWN IF THE CONSUMER WAS REACHING AT THE TIME OF THE INCIDENT. WARNING - "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. "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."

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE ROLLATOR WASHING DISHES WHEN THE WHEEL ALLEGEDLY BROKE OFF, CAUSING THE CONSUMER TO FALL TO THE GROUND. NINE-ONE-ONE WAS CALLED TO HELP THE CONSUMER GET OFF THE GROUND. THE MODEL NUMBER IS UNKNOWN. IT IS UNKNOWN WHAT THE WEIGHT CAPACITY IS FOR THE ROLLATOR. THE CONSUMER WEIGHS (B)(6). 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 UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 Other