BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2132202 · Received June 6, 2011

    Report

    Report Number
    1525712-2011-00244
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    April 30, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GENTEEL (MAXHEALTH)
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER WAS SITTING ON THE ROLLATOR WHEN THE WHEEL ALLEGEDLY BROKE OFF. ROLLATOR WAS APPROX 7 YEARS OLD AT THE TIME OF THE INCIDENT. MAINTENANCE HISTORY IS UNK. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN/IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME SO, IT IS UNK IF A MALFUNCTION OCCURRED, OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE, OR LACK MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. OPERATOR'S GUIDE HAS INSTRUCTIONS ON THE PROPER AND SAFE USE OF THE PRODUCT. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING ON THE ROLLATOR ON THE SIDEWALK, WHEN THE RIGHT FRONT WHEEL ALLEGEDLY BROKE AND THE CONSUMER FELL BACKWARDS ONTO THE GRASS. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ GENTEEL (MAXHEALTH) 68100-TA GT40601

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR