BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3326585 · Received August 28, 2013

    Report

    Report Number
    1525712-2012-02012
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    December 2, 2011
    Report Date
    October 30, 2012
    Manufacturer
    UNK
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) 2012 - RBS - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL AND SERIAL NUMBER/DATE CODE ARE UNK. THE CONSUMER IS A FEMALE. HOWEVER, AGE, HEIGHT AND WEIGHT ARE UNK. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNK. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNK. THE ALLEGED MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE ALLEGED UNSPECIFIED SERIOUS INJURY HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 - RBS - IT WAS REPORTED BY THE CONSUMER'S ATTORNEY THAT AN UNK FAULTY WAKER ALLEGEDLY CAUSED/CONTRIBUTED TO THE PT UNSPECIFIED INJURY. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED IF WE RECEIVE ADDITIONAL INFO ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421834 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other