BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 3232210 · Received July 24, 2012

    Report

    Report Number
    1000282279-2012-00012
    Event Type
    Malfunction
    Date Received
    July 24, 2012
    Report Date
    July 24, 2012
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL, SERIAL NUMBER/DATE CODE AND AGE OF PRODUCT ARE UNKNOWN. THE CONSUMER IS A FEMALE WHOSE AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. FAMILY MEMBER OF THE CONSUMER CALLED STATING THAT THE RIGHT SIDE HAND BRAKE ON THE UNKNOWN ROLLATOR ALLEGEDLY BROKE. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES RIGHT HAND SIDE HAND BREAK BROKE. NO INJURY ALLEGED. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other