BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2253392 · Received September 19, 2011

    Report

    Report Number
    1525712-2011-00529
    Date Received
    September 19, 2011
    Date of Event
    August 12, 2011
    Report Date
    September 17, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THE USER INSTRUCTIONS FOR MODEL 68100-TA IS PART NO 1150739 REV A - 07/08. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTANDS THE USER INSTRUCTIONS FOR THIS DEVICE. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN IS UNKNOWN. THE FOLLOWING WARNINGS ARE PROVIDED IN THE USER INSTRUCTIONS. IT IS UNKNOWN IF THE CONSUMER FOLLOWS THESE INSTRUCTIONS. FOLLOWING THESE INSTRUCTIONS MAY HAVE MITIGATED THE INCIDENT. "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 OWNERS 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 WALKLITE OR ROLLITE AS A WHEELCHAIR OR TRANSPORT DEVICE. WALKLITES AND ROLLITES ARE NOT INTENDED TO BE PROPELLED WHILE SEATED. A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE HEIGHT ADJUSTMENT OF THE PRODUCT FOR MAXIMUM SUPPORT AND STABILITY. MAKE SURE THAT ALL HARDWARE IS SECURE, ATTACHMENTS ARE SECURELY TIGHTEN AND LOCKED IN THE OPEN POSITION, AND THAT CASTERS AND MOVING OBJECTS ARE IN GOOD WORKING ORDER BEFORE USING THIS OR ANY MOBILITY AID. THE WHEELS AND GLIDE BRAKES MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES DURING USE. THE GLIDE BRAKES ARE INTENDED TO PROVIDE ADDITIONAL STABILITY WHILE IN THE SEATED POSITION. THE GLIDE BRAKES ARE NOT INTENDED TO BE USED FOR STOPPING THE WALKLITE DURING AMBULATION. DO NOT ROCK THE WALKLITE OR ROLLITE WHILE SITTING ON THE SEAT. ALWAYS OBSERVE THE WEIGHT LIMIT ON THE LABELING OF YOUR PRODUCT. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY. IF THE WALKLITE OR ROLLITE IS EXPOSED TO EXTREME TEMPERATURE (ABOVE 100°F OR BELOW 32°F), HIGH HUMIDITY AND/OR BECOMES WET, PRIOR TO USE, ENSURE HANDGRIPS DO NOT TWIST ON THE WALKLITE OR ROLLITE HANDLES - OTHERWISE DAMAGE OR INJURY MAY OCCUR. 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 WALKLITE OR ROLLITE AND MAY CAUSE THE UNIT TO TIP, RESULTING IN INJURY OR DAMAGE. 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. DO NOT HANG ANYTHING FROM THE FRAME OF THE WALKLITE OR ROLLITE. ITEMS SHOULD BE PLACED IN THE BASKET. THE BASKET HAS A WEIGHT LIMITATION OF 11 LBS (5 KG). ITEMS PLACED IN THE BASKET SHOULD NOT PROTRUDE FROM THE BASKET AS THIS MAY CAUSE THE PRODUCT TO TIP." THE CONSUMER IS (B)(6) WHICH MEETS THE HEIGHT REQUIREMENTS STATED BELOW: 68100-TA 5'11" - 6'6".

    Description of Event or Problem · 1

    THE CONSUMER WAS WALKING OUTSIDE ON A CEMENT DECK, WHEN THE WHEEL ALLEGEDLY CAUGHT ON SOMETHING AND HE FELL. 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 GENTEEL (MAXHEALTH) 68100-TA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other