BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3268590 · Received August 7, 2013

    Report

    Report Number
    1531186-2013-03675
    Date Received
    August 7, 2013
    Report Date
    July 24, 2013
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL PR (B)(4) ISSUED MFR. REPORT # 15331186-2013-03675, INDICTING THE BRAND NAME AS A MECHANICAL (MANUAL) WHEELCHAIR WITH A COMMON DEVICE NAME OF 890.3850. THE CORRECT BRAND NAME IS MECHANICAL WALKER, ROLLATOR WITH A COMMON DEVICE NAME OF 890.3825.

    Description of Event or Problem · 1

    DEALER STATES BRAKE HANDLE BROKE OFF OF THE ROLLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371238 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ HL CORP. (SHENZHEN) 65650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other