BEUDAMED
    FDA Adverse Event Other Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2114273 · Received May 27, 2011

    Report

    Report Number
    1525712-2011-00215
    Event Type
    Other
    Date Received
    May 27, 2011
    Date of Event
    April 30, 2011
    Report Date
    May 27, 2011
    Manufacturer
    INVACARE
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER WAS USING THE ROLLATOR OUTSIDE AND SAT DOWN ON THE SEAT, WHEN UNIT ALLEGEDLY COLLAPSED AND HE FELL BACKWARDS. PAST HISTORY WITH SIMILAR PRODUCTS INDICATES THAT USER INSTABILITY AND SUDDEN / IMPROPER DEVICE LOADING IS THE MOST LIKELY CAUSE OF THIS INCIDENT. IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE OCCURRED. NO SERIOUS INJURY HAS BEEN REPORTED. MDR FILED BASED ON ALLEGED UNCONFIRMED MALFUNCTION.

    Description of Event or Problem · 1

    THE CONSUMER SAT ON THE ROLLATOR WHEN THE UNIT ALLEGEDLY COLLAPSED, CAUSING THE CONSUMER TO FALL BACKWARDS AND HIT HIS HEAD ON THE SIDEWALK. THE CONSUMER ALLEGEDLY SUSTAINED A BUMP ON HIS HEAD. NO MEDICAL TREATMENT WAS GIVEN. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVACARE 65650 MX090415

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR