BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR, GUARDIAN, ECONO, ALUMINUM, BLUE

    MDR report key: 2042062 · Received March 29, 2011

    Report

    Report Number
    1417592-2011-00016
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 12, 2011
    Report Date
    March 25, 2011
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS REPORTED TO US THROUGH A THIRD PARTY AND NOT THE END USER. THE END USER WAS RISING FROM A SITTING POSITION AND GRABBED THE ROLLATOR. IT MOVED FORWARD AND SHE LOST HER BALANCE AND FELL. TWO DAYS LATER, A FRACTURED HIP WAS DIAGNOSED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND NO LOT NUMBER WAS PROVIDED. IT WAS REPORTED THAT THE BRAKE WAS APPLIED AT THE TIME OF THE INCIDENT BUT THAT IT FAILED. THE OVERALL CONDITION OF THE DEVICE IS NOT KNOWN OR IF MAINTENANCE HAD BEEN PERFORMED. WITHOUT THE SAMPLE, IT CANNOT BE DETERMINED IF MAINTENANCE WAS EVER DONE ON THE UNIT'S BRAKES OR IF THEY HAD BEEN ADJUSTED CORRECTLY. A DEFINITIVE CONCLUSION OF THE OPERATION OF THE BRAKES CANNOT BE MADE. DUE TO THE REPORTED INJURY AND NEED FOR SUBSEQUENT HOSPITALIZATION AND SURGERY, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN RISING FROM A SITTING POSITION, THE WALKER MOVED AND THE END USER LOST HER BALANCE AND FELL. SHE SUSTAINED A HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR, GUARDIAN, ECONO, ALUMINUM, BLUE NONE ITJ G07886B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other