BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROBASICS

    MDR report key: 8287267 · Received January 29, 2019

    Report

    Report Number
    3012316249-2019-00003
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    December 19, 2019
    Report Date
    January 29, 2019
    Manufacturer
    AIKIN HOLDING CORP.
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END-USER CALLED IN ABOUT A ROLLATOR SHE HAD FOR TWO YEARS. SHE STATED SHE HAS SINCE TAKEN THE DEVICE BACK TO WHERE SHE PURCHASED IT FROM MULTIPLE TIMES FOR REPAIRS. THE LEFT FRONT WHEEL IS BENT IN, CAUSING THE WHEEL TO BECOME VERY WOBBLY. ON (B)(6) 2019, THE END-USER WAS AT HOME WALKING THRU THE HALLWAY, AND THE WHEEL BECAME VERY UNSTABLE. THE END-USER HIT HER HEAD ON THE WALL. SHE STATED THAT DUE TO HITTING HER HEAD, IT CAUSED A BIG HEMATOMA ON THE FRONT OF HER HEAD. PARAMEDICS WERE CALLED TO THE SCENE, AND SHE WAS TAKEN TO THE HOSPITAL WHERE STAFF PERFORMED A CATSCAN. THE CATSCAN RESULTS CAME BACK NORMAL. SHE WAS GIVEN SOMETHING FOR PAIN, AND WAS DISCHARGED. THE WHEEL IS NOTED AS STILL BEING ATTACHED TO THE ROLLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77549 PROBASICS ROLLATOR ITJ AIKIN HOLDING CORP. PB1025LP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R