BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR

    MDR report key: 3143184 · Received May 24, 2013

    Report

    Report Number
    1417592-2013-00046
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER REPORTED THAT HE WAS SITTING ON THE SEAT OF THE ROLLATOR, REACHED FOR SOMETHING IN HIS REFRIGERATOR AND FELL WHEN ONE OF THE WHEELS SUDDENLY BROKE. HE DID NOT SEEK MEDICAL ATTENTION UNTIL ONE WEEK LATER AND WAS HOSPITALIZED FOR TWO DAYS FOR RIGHT SHOULDER AND NECK PAIN. NO FRACTURE OR OTHER SERIOUS INJURY WAS DIAGNOSED. HE WAS DISCHARGED WITH RECOMMENDATIONS TO HAVE PHYSICAL THERAPY. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER WAS REPORTED. WE HAVE NOT CONFIRMED THE ISSUE OR IDENTIFIED A ROOT CAUSE.

    Description of Event or Problem · 1

    WHILE SITTING ON THE ROLLATOR, THE WHEEL BROKE AND HE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232018 ROLLATOR ITJ MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O