BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2716580 · Received August 28, 2012

    Report

    Report Number
    1531186-2012-00792
    Date Received
    August 28, 2012
    Report Date
    August 27, 2012
    Manufacturer
    R. POON
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 66500 SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE OWNER'S MANUAL PART NUMBER 1148077 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4): RECEIVED EMAIL FROM (B)(4) REGARDING A DISCONTINUED 66500. CHECKED WITH QUALITY FOR WARRANTY REPLACEMENT ISSUES - GO AHEAD WITH WARRANTY REPLACEMENT. ACCORDING TO MIKE AT DAKOTA "THE BOLT INSIDE THE TUBING HOUSING THE FRONT CASTER ASSEMBLY HAD SNAPPED OFF. PATIENT IS UNDER THE WEIGHT LIMIT. LOT NUMBER 101108." REPLACED UNDER WARRANTY (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ R. POON 66500 101108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other