BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATOR 9153651315

    MDR report key: 4790252 · Received May 22, 2015

    Report

    Report Number
    9615290-2015-00196
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    January 6, 2015
    Report Date
    April 30, 2015
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT, A SUPPLEMENTAL RECORD WILL BE FILED. THE FUTURA/FRONT FORK IS THE SAME /SIMILAR TO A PRODUCT OR PRODUCTS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S.

    Description of Event or Problem · 1

    THE PATIENT WENT TO THE WALKER INDOORS WITH SUPERVISION WHEN THE PLASTIC ON THE RIGHT FRONT FORK BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334310 ROLLATOR 9153651315 WALKER, MECHANICAL ITJ DOLOMITE AB FUTURA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other