BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2771370 · Received October 4, 2012

    Report

    Report Number
    1531186-2012-01091
    Date Received
    October 4, 2012
    Report Date
    October 2, 2012
    Manufacturer
    HEALTHPLUS
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSING ASSISTANT

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER CARE TAKER, THE BACK RIGHT LEG BROKE RIGHT IN HALF. NO INJURY HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ HEALTHPLUS 6240-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other