BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER LIGHT ROLLATOR

    MDR report key: 4860122 · Received June 18, 2015

    Report

    Report Number
    1417592-2015-00049
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 11, 2015
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE SITTING ON THE ROLLATOR, THE END USER WAS BEING PUSHED ACROSS A STREET AND UP A METAL RAMP. THE ROLLATOR COLLAPSED AND THE END USER FELL, HITTING HER HEAD ON THE RAMP. SHE SUSTAINED RIGHT RIB FRACTURES, A RIGHT OCCIPITAL SKULL FRACTURE AND A HEAD LACERATION THAT WAS REPAIRED WITH MINOR SUTURING. SHE WAS ADMITTED INTO THE HOSPITAL, THE DEVICE IS NOT INTENDED TO BE USED AS A TRANSPORT DEVICE WHILE SOMEONE IS SITTING ON IT. THE REPORTER, WHO IS THE END USER'S SON, CONFIRMED THAT HE DID RECEIVE A MANUAL WITH THE ROLLATOR. IN THE MANUAL IT STATES "DO NOT ATTEMPT TO MOVE THE ROLLATOR WHILE YOU OR ANYONE IS SITTING ON THE SEAT." A SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AND NO PHOTOS WERE SENT. THE OVERALL CARE AND CONDITION OF THE ROLLATOR IS NOT KNOWN. WE HAVE NO INFORMATION TO INDICATE A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE INCIDENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. BASED ON THE INFORMATION PROVIDED, WE CANNOT RULE OUT USER ERROR.

    Description of Event or Problem · 1

    THE END USER WAS SITTING ON THE ROLLATOR AND BEING PUSHED. SHE FELL AND SUFFERED RIGHT RIB AND SKULL FRACTURES. SHE WAS ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397067 SUPER LIGHT ROLLATOR ITJ MEDLINE INDUSTRIES, INC. M140772163

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| O| R