BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOLOMITE MAXI ROLLATOR 650 7331492560417

    MDR report key: 4423461 · Received January 15, 2015

    Report

    Report Number
    9615290-2015-00022
    Event Type
    Malfunction
    Date Received
    January 15, 2015
    Report Date
    January 5, 2015
    Manufacturer
    DOLOMITE AB
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL MANUFACTURER REPORT # 961529-2015-00022 WAS SUBMITTED TO THE FDA ON 01/15/2015. A CORRECTION HAS BEEN MADE TO THE INITIAL REPORTER, E1. THIS IS A CANADIAN EVENT, WITH A (B)(6) DEALERSHIP LOCATION.

    Description of Event or Problem · 1

    PER PROVIDER THE RIGHT SIDE WELD BROKE ON FRAME.

    Description of Event or Problem · 1

    PER PROVIDER THE RIGHT SIDE WELD BROKE ON FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35517 DOLOMITE MAXI ROLLATOR 650 7331492560417 WALKER, MECHANICAL ITJ DOLOMITE AB JAZZSTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other