BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECHANICAL WALKER 890.3825

    MDR report key: 2750657 · Received March 26, 2008

    Report

    Report Number
    3004496806-2008-00026
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 21, 2008
    Manufacturer
    HL CORP
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    USER REPORTED WAS TRANSGRESSING WITH HER PRODUCT AND IS UNSURE IF IT WAS THE PRODUCT OR HOW SHE HAD USED IT THAT RESULTED IN HER FALL. CURRENT USER GUIDE COVERS THIS AREA. MDR FILED BASED ON INJURY.

    Description of Event or Problem · 1

    THE CONSUMER WAS USING THE KNEE WALKER FOR ABOUT 2 WEEKS WHEN SHE WENT OVER TOP OF THE WALKER, RESULTING IN A SURGERY TO REPAIR THE ORIGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL WALKER 890.3825 ITJ HL CORP 65950

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention