BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR, SUPER LIGHT, 250LB CAP

    MDR report key: 1406872 · Received June 11, 2009

    Report

    Report Number
    1417592-2009-00035
    Event Type
    Other
    Date Received
    June 11, 2009
    Report Date
    June 5, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE END USER SAT DOWN ON THE ROLLATOR AND ONE BRAKE DID NOT LOCK. SHE FELL AND FRACTURED A COUPLE OF RIBS. SHE WAS REPORTED TO BE DOING WELL. THE SAMPLE WAS RETURNED AND EVALUATED. THE FRONT AND REAR LEG EXTENSIONS WERE NOT SET EVENLY. THE REAR EXTENSIONS WERE SET AT ADJUSTMENT HOLE 1, AND THE FRONT EXTENSIONS WERE SET AT ADJUSTMENT HOLE 2. SINCE THE FRONT EXTENSIONS WERE SET HIGHER, IT GIVES THE SEAT A DOWNWARD SLOPING ANGLE. IT WAS CONFIRMED THAT THE LEFT BRAKE LOCKED AND THE RIGHT BRAKE DID NOT LOCK. WITH ADJUSTMENT, THE RIGHT BRAKE LOCKED AS SPECIFIED BY THE MANUFACTURER. INSTRUCTIONS FOR SET UP AND DEVICE MAINTENANCE ARE DESCRIBED IN THE OWNER'S MANUAL. THIS IS NOT A MANUFACTURING DEFECT AND THE INCIDENT APPEARS TO BE CAUSED BY A LACK OF MAINTENANCE. HOWEVER, DUE TO THE REPORT OF FRACTURED RIBS, THIS MDR IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE END USER SAT DOWN ON THE ROLLATOR AND THE BRAKE DID NOT LOCK. SHE FELL, FRACTURING SOME RIBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR, SUPER LIGHT, 250LB CAP NONE ITJ MEDLINE INDUSTRIES, INC. MDS86825SLR A080926942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other