BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2223294 · Received August 25, 2011

    Report

    Report Number
    1525712-2011-00465
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 25, 2011
    Manufacturer
    UNKNOWN
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS ROLLATOR. THE MANUFACTURER OF THIS DEVICE IS UNKNOWN. MANUFACTURER LETTERS WILL BE SENT TO ALL KNOWN MANUFACTURERS USED BY INVACARE OF THIS DISTRIBUTED MODEL. ROLLATOR MODEL 65851R SN UNKNOWN. THE CONSUMER IS (B)(6) AND MEETS THE HEIGHT LIMITS FOR THE 65851R 5'6" - 6'3". THE CONSUMER WEIGHTS (B)(6) WHICH MEETS THE WEIGHT LIMIT OF 300 LBS. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND FOLLOWED THE WARNINGS PROVIDED IN THE USER INSTRUCTIONS PART NO 1148077 PAGE 1. FOLLOWING THESE WARNINGS MAY HAVE PREVENTED THE CONSUMER FROM FALLING IN HIS GARAGE. 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. 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. 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. 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

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE FRONT BARS BENT AND HE FELL BACKWARDS HITTING HIS HEAD ON THE FLOOR. THE CONSUMER ALLEGEDLY WENT TO THE HOSPITAL AND SUSTAINED INJURIES. THE SPECIFIC AND EXTENT OF THE ALLEGED INJURIES ARE NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANE, CRUTCH AND WALKER TIPS AND PADS 890.3790 INP UNKNOWN 65851R

    Patients

    Seq Age Sex Outcome Treatment
    1 81 Other