BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLITE ROLLATOR 9153637242

    MDR report key: 9215405 · Received October 21, 2019

    Report

    Report Number
    1531186-2019-00007
    Event Type
    Injury
    Date Received
    October 21, 2019
    Report Date
    October 8, 2019
    Manufacturer
    GENTEEL
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AIDE FOR THE END-USER STATED; THAT THE BRAKES ON THE ROLLATOR HAVE BEEN BROKEN FOR OVER A YEAR. ASSEMBLY, INSTALLATION AND OPERATING INSTRUCTIONS ON PAGE 1 PART #1150739 STATES; "THE WHEELS AND GLIDE BRAKES MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES DURING USE. THE GLIDE BRAKES ARE INTENDED TO PROVIDE ADDITIONAL STABILITY WHILE IN THE SEATED POSITION. THE GLIDE BRAKES ARE NOT INTENDED TO BE USED FOR STOPPING THE WALKLITE DURING AMBULATION." CARE AND MAINTENANCE ON PAGE 2 STATES; VERIFY OPERATION OF THE BRAKES AND ADJUST THEM AS NECESSARY. IF HANDGRIPS ARE LOOSE, DO NOT USE THE PRODUCT. CONTACT YOUR INVACARE DEALER. INSPECT WHEELS PERIODICALLY FOR WEAR AND DAMAGE. REPLACE ANY BROKEN, DAMAGED OR WORN ITEMS IMMEDIATELY. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE VERIFIED, AND THE UNDERLYING CAUSE COULD NOT BE DETERMINED. THIS IS A DISTRIBUTED PRODUCT AND THIS REPORT WILL BE SENT TO THE MANUFACTURE, (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE END-USER WAS WALKING FROM THE BEDROOM TO THE LIVING ROOM, WHEN THE ROLLATOR ROLLED TO THE SIDE, CAUSING END-USER TO START TO FALL. THE AIDE GRABBED HER FROM BEHIND, PUT THEIR HANDS ACROSS THE PATIENT¿S CHEST, AND HUGGED HER. THE END-USER WAS ADMITTED TO THE HOSPITAL DUE TO CHEST PAINS FROM WHERE AID GRABBED HER AND ALLEGED SORENESS AND PAIN FROM THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007065 ROLLITE ROLLATOR 9153637242 WALKER, MECHANICAL ITJ GENTEEL NA:65100

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization