BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL WALKER, ROLLATOR

    MDR report key: 4945044 · Received June 14, 2013

    Report

    Report Number
    1000282279-2013-00060
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: CONSUMER STATES NOTHING SEEMS WRONG WITH THE WALKER. END USER IS MY MOTHER IN LAW AND IS IN A NURSING HOME. SHE IS NOT SUPPOSED TO GET UP AND MOVE BY HERSELF, BUT DID. SHE USES (B)(6) INVACARE WALKER WITH NON INVACARE TENNIS BALLS ON THE FRONT AND NON INVACARE SKIDS ON THE BACK TO GO TO THE BATHROOM AND SOMEHOW FELL IN THE BATHROOM AND GOT STUCK BETWEEN THE TOILET AND THE WALL FOR UNK PERIOD OF TIME UNTIL NURSING HOME STAFF FOUND HER. SHE WAS TRANSPORTED TO (B)(6) ER AND THEN ADMITTED TO EMH. NO REPORTS OF HEAD INJURY. MINOR KNEE INJURY. MAIN REASON SHE WAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272408 MECHANICAL WALKER, ROLLATOR ITJ FOSHAN R. POON MEDICAL PRODUCTS CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other