BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROLLATOR 9153651315

    MDR report key: 4862558 · Received June 23, 2015

    Report

    Report Number
    1525712-2015-03500
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Report Date
    May 27, 2015
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CONSUMER STATED, THE REAR WHEEL HAS BROKE. SHE STATED SHE IS OK, SHE NEEDS THE ROLLATOR BECAUSE, SHE FALLS A LOT. THE CONSUMER IS ELDERLY SHE HAS A HARD TIME SEEING. THE LOT NUMBER MAY NOT BE CORRECT. SHE DID NOT KNOW HER MODEL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405959 ROLLATOR 9153651315 WALKER, MECHANICAL IOR UNKNOWN SELFCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other