BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROLLATOR, BLUE, 250 LBS, CURVED

    MDR report key: 1341297 · Received March 10, 2009

    Report

    Report Number
    1417592-2009-00012
    Event Type
    Other
    Date Received
    March 10, 2009
    Date of Event
    June 12, 2008
    Report Date
    March 6, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO US THAT END USER WAS STANDING GRIPPING THE ROLLATOR ON THE BACK BY HANDLES AND SHE FELL BACKWARD HITTING HER HEAD AT THE EDGE OF THE COUNTERTOP TABLE. SHE WENT TO THE ER AND RECEIVED 7 STITCHES. DEVICE WAS NOT RETURNED FOR EVALUATION. PHOTOS WERE PROVIDED. THE PICTURES SHOW SHE WAS STANDING WITH HER BACK FACING THE ROLLATOR AND SHE WAS GRIPPING HANDLES OF THE ROLLATOR. SHE WAS SHOWING HOW SHE FELL WHILE LEANING ON THE ROLLATOR AND THE RIGHT FRONT WHEEL FELL OFF. SHE FELL BACKWARDS AS SHE WAS LEANING AGAINST THE ROLLATOR IN THIS POSITION. THIS IS NOT THE PROPER USE OF ROLLATOR. END USER SHOULD NOT LEAN ON THE ROLLATOR FROM THE BACK WHILE IN A STANDING POSITION. THE PICTURES SHOW A PORTION OF ONE OF THE THREADS OF THE WHEEL BOLT TO BE STRIPPED. THREADS ON THE ALUMINIUM TUBING ARE SEEN STRIPPED AS WELL. THE MANUAL REQUIRES END USERS TO CHECK PARTS TO MAKE SURE THEY ARE SECURE BEFORE USE AND CONFIRM THEY ARE IN GOOD WORKING ORDER. ACCORDING TO THE REPORT THE END USER USED THIS ROLLATOR FOR 25 MONTHS. THE PHOTOS SUGGEST MAINTENANCE HAD NOT BEEN DONE. PROPER MAINTENANCE AND VERIFICATION OF THE OPERATION OF THE ROLLING WALKER IS NECESSARY TO ASSURE THE PRODUCT. REMAINS IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL MONTHS AGO THE END USER WAS STANDING WITH THE ROLLATOR BEHIND HER. SHE WAS GRIPPING THE ROLLATOR BEHIND HER BY THE HANDLES WHEN APPARENTLY THE WHEEL CAME OFF AND SHE FELL BACKWARD HITTING HER HEAD AT THE EDGE OF THE COUNTER. SHE RECEIVED SEVEN STITCHES TO HER HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROLLATOR, BLUE, 250 LBS, CURVED NONE ITJ MEDLINE INDUSTRIES, INC. MDS86810B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other