BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREX ROLLING WALKER

    MDR report key: 5138857 · Received October 8, 2015

    Report

    Report Number
    2182780-2015-00011
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    July 6, 2014
    Report Date
    October 8, 2015
    Manufacturer
    R. POON MEDICAL PRODUCTS
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS JUST RECENTLY DISCOVERED WITHIN THE CORPORATE OFFICE OF CAREX. CAREX WAS PURCHASED BY COMPASS HEALTH BRANDS IN 2014, AND FINAL INTEGRATION OF THE CAREX COMPLAINT MANAGEMENT SYSTEM INTO THE COMPASS HEALTH BRANDS COMPLAINT MANAGEMENT SYSTEM HAS JUST BEEN COMPLETED. DUE TO THE AGE OF THIS COMPLAINT, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    (B)(6) WOMAN, WAS USING ROLLING WALKER WHEN SHE TRIPPED OVER THE REAR WHEEL AND FELL. AS SHE FELL TO THE GROUND THE PROTRUSIONS FROM YOUR WALKER WHICH ARE UNCAPPED AND CONSTITUTE A DANGEROUS CONDITION CUT A DEEP PUNCTURE WOUND INTO HER LEFT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665200 CAREX ROLLING WALKER ROLLATOR ITJ R. POON MEDICAL PRODUCTS FGA22200 0000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other