BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2718765 · Received August 29, 2012

    Report

    Report Number
    9616091-2012-00289
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Report Date
    August 27, 2012
    Manufacturer
    INVAMEX
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 12120-37-23, THE OWNER'S MANUAL IS FOUND ON-LINE AT INVACARE.COM. 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. SON, ALLEGED THAT THE CASTERS ARE FOLDING UP AND THE LEGS ARE LEANING TO THE SIDE AND STATED HIS FATHER HAS ALREADY FALLEN TWICE BECAUSE OF THIS. THE SON STATED EVEN THOUGH HE FELL HE WAS NOT HURT OR INJURED BECAUSE OF THE FALL. THE SON DOES NOT HAVE THE DATE CODE FROM THE ROLLATOR BECAUSE HE IS NOT WITH IT AT THIS TIME.

    Description of Event or Problem · 1

    SON, (B)(6), ALLEGED THAT THE CASTERS ARE FOLDING UP AND THE LEGS ARE LEANING TO THE SIDE AND STATED HIS FATHER HAS ALREADY FALLEN TWICE BECAUSE OF THIS. (B)(6) STATED EVEN THOUGH HE FELL HE WAS NOT HURT OR INJURED BECAUSE OF THE FALL. (B)(6) DOES NOT HAVE THE DATE CODE FROM THE ROLLATOR BECAUSE HE IS NOT WITH IT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVAMEX 12120-37-23

    Patients

    Seq Age Sex Outcome Treatment
    1 70 Other