BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALER, ROLLATOR

    MDR report key: 3232201 · Received October 4, 2012

    Report

    Report Number
    1000282279-2012-00031
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 21, 2012
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DEALER STATED THAT THE 66500 BARIATRIC ROLLATOR BRAKES WERE ADJUSTED AS FAR AS THEY WOULD GO, AND IT STILL NOT HOLDING, AND AS A RESULT, THE CONSUMER SLID DOWN TO THE FLOOR. HOWEVER, THERE WAS NO INJURY REPORTED. REF (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALER, ROLLATOR WALKER ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. 66550

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other