BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3160659 · Received June 10, 2013

    Report

    Report Number
    1525712-2013-04527
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    June 6, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ATTORNEY STATES THE END-USER DIED SEVERAL MONTHS AFTER THE FALL AND BELIEVES THE WALKER FAILURE AND FALL COULD BE LINKED TO THE END-USER DEATH. EMAILS RECEIVED FROM AN ATTORNEY STATING A LAWSUIT IS BEING FILED AGAINST INVACARE.

    Description of Event or Problem · 1

    THE INCIDENT IS DESCRIBED AS THE END-USER FELL WHEN THE TWO FRONT LEGS SNAPPED ON WALKER WHILE THE END-USER WAS RECOVERING FROM HIP SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260700 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNKNOWN 6291-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death