BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 2563151 · Received May 8, 2012

    Report

    Report Number
    1531186-2012-00198
    Date Received
    May 8, 2012
    Report Date
    April 30, 2012
    Manufacturer
    HL CORP. (SHENZHEN)
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER IS A (B)(6) MALE, (B)(6). THE CONSUMERS PREEXISTING MEDICAL CONDITION STATES HE IS RECOVERING FROM ANKLE SURGERY. THE CONSUMERS STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER STATED THAT THE BOLT THAT HOLDS THE BEARINGS CAME OFF AND THE WHEEL FELL OFF THE ROLLATOR. NO INJURY OR MEDICAL INTERVENTION. THE CONSUMER IS CURRENTLY USING A WHEELCHAIR AND CRUTCHES. THE CONSUMER ORDERED THE REPLACEMENT PART THROUGH LOCAL DEALER AND WILL HAVE THE REPAIR MADE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE RIGHT SIDE BEARINGS ON THE FRONT BLEW OUT PART (B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER, ROLLATOR 890.3825 ITJ HL CORP. (SHENZHEN) 65950

    Patients

    Seq Age Sex Outcome Treatment
    1 57 Other