BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3200372 · Received July 1, 2013

    Report

    Report Number
    1525712-2013-05213
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP #001 INITIAL (B)(4) ISSUED MFR. REPORT # 1525712-2013-05213 INDICTING THAT THE PRODUCT WAS A COMPASS SPT MANUAL WHEELCHAIR. THE CORRECT PRODUCT IS A 12160 DOLOMITE SYMPHONY ROLLATOR. THIS PRODUCT IS NOT DISTRIBUTED IN THE USA, THEREFORE, NO REPORT TO THE USA FDA IS NECESSARY. THE INCIDENT HAPPENED IN (B)(6).

    Description of Event or Problem · 1

    THE PROVIDER REPORTED THE THREADING INSIDE THE FRAME AT THE HINGE ON THE COMPASS SPT MANUAL WHEELCHAIR ARE STRIPPED. AS A RESULT, THE BOLT CANNOT BE SECURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299780 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ INVACARE TAYLOR STREET 12160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other