BEUDAMED
    FDA Adverse Event Summary report: N

    CANE, CRUTCH AND WALKER TIPS AND PADS

    MDR report key: 2230019 · Received August 31, 2011

    Report

    Report Number
    1525712-2011-00482
    Date Received
    August 31, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 31, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. THE DEALER FOUND THE LEG LOCK NOT LOCKING ISSUE AFTER UNBOXING THE DEVICE. THE DEALER FOLLOWED THE PROPER PROTOCOL AND QUARANTINED THE DEVICE PREVENTING IT FROM GETTING INTO THE FIELD. THE USER INSTRUCTIONS FOR MODEL 6291-JR5F IS PART NUMBER 1148077. THE AGE OF THE DEVICE IS UNKNOWN BUT IT IS ASSUMED TO BE A NEW DEVICE. REV F OF THE USER INSTRUCTIONS WAS REFERENCED IN THIS DOCUMENTATION. MAINTENANCE INSTRUCTIONS FOUND ON PAGE 2 OF THE USER INSTRUCTIONS, SPECIFICALLY BELOW, PREVENTED THE DEVICE FROM GETTING INTO THE FIELD. "CARE AND MAINTENANCE: VERIFY OPERATION OF THE BRAKES AND HAVE THEM ADJUSTED IF NECESSARY. CONTACT YOUR INVACARE DEALER FOR BRAKE ADJUSTMENT. IF HAND GRIP IS LOOSE, DO NOT USE. CONTACT YOUR INVACARE DEALER. INSPECT WHEELS PERIODICALLY FOR WEAR OR DAMAGE. REPLACE ANY BROKEN, DAMAGED OR WORN ITEMS IMMEDIATELY. FOR THE BEST SERVICE FROM YOUR ROLLATOR, ALWAYS USE REPLACEMENT PARTS FROM INVACARE. PERIODICALLY INSPECT THE CASTERS AND CASTER STEMS FOR ASSEMBLY TIGHTNESS AND VERIFY THAT THE WHEELS ARE FREE OF HAIR, LINT AND OTHER DEBRIS THAT COULD INTERFERE WITH FREE WHEEL OPERATION."

    Description of Event or Problem · 1

    THE DEALER TOOK THE WALKERS OUT OF THE BOX AND FOUND THAT ONE SIDE WOULD ALLEGEDLY NOT LOCK PROPERLY. NO CONSUMER INVOLVED. NO INJURY 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) 6291-JR5F

    Patients

    Seq Age Sex Outcome Treatment
    1 Other