BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSENTIAL ROLLATOR

    MDR report key: 1532182 · Received November 9, 2009

    Report

    Report Number
    1056127-2009-00021
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 8, 2009
    Manufacturer
    ESSENTIAL MEDICAL SUPPLY, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS UNDER RECALL PT HAD BEEN INDIVIDUALLY NOTIFIED TO RETURN UNIT, BUT DID NOT.

    Description of Event or Problem · 1

    FRONT CASTER DETACHED ON RECALLED UNIT. PT FELL, HAD BRUISES, HOSPITALIZED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSENTIAL ROLLATOR WALKER, MECHANICAL ITJ ESSENTIAL MEDICAL SUPPLY, INC. W1700

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization