BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2132177 · Received June 6, 2011

    Report

    Report Number
    1525712-2011-00245
    Event Type
    Other
    Date Received
    June 6, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    R. POON
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. CONSUMER STATED THAT WHEEL FELL OFF. PRODUCT WAS APPROX 1 1/2 YEARS OLD AT TIME OF 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 DR'S VISIT.

    Description of Event or Problem · 1

    THE WHEEL ALLEGEDLY FELL OFF, CAUSING THE CONSUMER TO FALL. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ R. POON 66500 RP090909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention