BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 25195148 · Received May 16, 2026

    Report

    Report Number
    1417592-2026-01379
    Event Type
    Malfunction
    Date Received
    May 16, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 16, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHEN ENGAGING THE HAND BRAKES, THE WERE NOT WORKING PROPERLY AND 'DID NOT DIG INTO THE WHEELS'. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN ENGAGING THE HAND BRAKES, THEY WERE NOT WORKING PROPERLY AND 'DID NOT DIG INTO THE WHEELS'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562340 MEDLINE ROLLATOR, BASIC, BLACK, STEEL, 8" ITJ MEDLINE INDUSTRIES, LP 88524090003

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male