BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2247974 · Received September 14, 2011

    Report

    Report Number
    1525712-2011-00512
    Date Received
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THE DEVICE. MODEL 6300-ATA WALKER USES OWNERS INSTRUCTIONS PART NUMBER 1150739 REV A [JUL-08]. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNERS INSTRUCTIONS. THE FOLLOWING WARNING IS PROVIDED TO THE CONSUMER. "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 IS CONSULTED A DR. OR THERAPIST TO DETERMINE THE CORRECT ADJUSTMENTS. THE MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN OF THE CONSUMER ARE UNKNOWN. THE FOLLOWING WARNINGS ARE PROVIDED TO THE CONSUMER. "EACH INDIVIDUAL SHOULD ALWAYS CONSULT WITH THEIR PHYSICIAN OR THERAPIST TO DETERMINE PROPER ADJUSTMENT AND USAGE." "A PHYSICAL/OCCUPATIONAL THERAPIST SHOULD ASSIST IN THE HEIGHT ADJUSTMENT OF THE PRODUCT FOR MAXIMUM SUPPORT AND STABILITY." THE CONSUMER IS (B)(6). THE CONSUMER DOES NOT MEET THE HEIGHT REQUIREMENTS FOR THIS DEVICE. WALKLITE MODELS: 6300-ATA PATIENT HEIGHT MIN. / MAX.: 5'5" - 6'5". IT IS UNKNOWN IF THE CONSUMER SELF PROPELS IN THE DEVICE. THE FOLLOWING WARNING IS PROVIDED. "DO NOT USE THE WALKLITE OR ROLLITE AS A WHEELCHAIR OR TRANSPORT DEVICE. WALKLITES AND ROLLITES ARE NOT INTENDED TO BE PROPELLED WHILE SEATED." THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE FOLLOWING WARNING IS PROVIDED: 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 CONSUMERS TECHNIQUE USING THE WALKER IS UNKNOWN. THE FOLLOWING WARNINGS ARE PROVIDED: "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." "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." THE CONSUMER WEIGHT IS (B)(6). IT IS UNKNOWN IF ADDITIONAL LOADING IS BEING PLACED ON THE DEVICE. THE FOLLOWING WARNING IS PROVIDED. "ALWAYS OBSERVE THE WEIGHT LIMIT ON THE LABELING OF YOUR PRODUCT. CHECK THAT ALL LABELS ARE PRESENT AND LEGIBLE. REPLACE IF NECESSARY." "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." IT IS UNKNOWN IF THE DEVICE HAS BEEN EXPOSED TO EXTREME TEMPERATURES. THE FOLLOWING WARNING IS PROVIDED. "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." IT IS UNKNOWN IF NON-INVACARE ACCESSORIES ARE USED ON THE WALKER. THE FOLLOWING WARING IS PROVIDED. "ACCESSORIES WARNING: INVACARE PRODUCTS ARE SPECIFICALLY DESIGNED AND MANUFACTURED FOR USE IN CONJUNCTION WITH INVACARE ACCESSORIES. ACCESSORIES DESIGNED BY OTHER MANUFACTURERS HAVE NOT BEEN TESTED BY INVACARE AND ARE NOT RECOMMENDED FOR USE WITH INVACARE PRODUCTS."

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES SHE FELL TWICE DUE TO THE WALKER BEING LOOSE. 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) 6300-ATA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 MO Other