BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATOR 9153651315

    MDR report key: 4813314 · Received June 2, 2015

    Report

    Report Number
    9615290-2015-00200
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    April 2, 2015
    Report Date
    May 18, 2015
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ALPHA BASIC 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

    DURING USE ONE FRONT CASTER DID BLOCK AND THE PATIENT DID FALL WITH THE ROLLATOR TO THE FLOOR. PATIENT SUFFERED DAMAGE TO A TOOTH AND A GRAZE. THE ALPHA BASIC IS THE SAME /SIMILAR TO A PRODUCT OR PRODUCTS WHICH ARE, OR HAVE BEEN MANUFACTURED AND/OR MARKETED BY INVACARE IN U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354426 ROLLATOR 9153651315 WALKER, MECHANICAL ITJ DOLOMITE AB ALPHA BASIC

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other