BEUDAMED
    FDA Adverse Event Other Summary report: N

    WALKER, GUARDIAN W/5" WHEELS YOUTH

    MDR report key: 1593660 · Received January 13, 2010

    Report

    Report Number
    1417592-2010-00003
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    November 25, 2009
    Report Date
    January 12, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER STATED THE WALKER COLLAPSED ON HER AND SOMEHOW CUT HER LEG BELOW HER KNEE. SHE DID NOT REQUIRE STITCHES AND SAID IT WAS MORE OF A TEAR. SHE DOES NOT KNOW HOW IT HAPPENED BECAUSE SHE SAID IT HAPPENED SO FAST. SHE HAS BEEN ON PREDNISONE AND AS A RESULT, HER SKIN IS VERY FRAGILE. SHE WAS TAKEN TO THE ER. SHE HAS BEEN SEEN BY HOME HEALTH NURSES FOR DRESSING CHANGES. SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. WITHOUT THE SAMPLE TO EVALUATION, WE ARE UNABLE TO DETERMINE A POTENTIAL ROOT CAUSE FOR THE WALKER TO COLLAPSE OR DETERMINE SPECIFICALLY WHAT MIGHT HAVE CUT HER LEG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WALKER COLLAPSED ONTO THE END USER. SHE DID NOT FALL BUT IT SOMEHOW CUT HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALKER, GUARDIAN W/5" WHEELS YOUTH NONE ITJ MEDLINE INDUSTRIES, INC. G30758W A090639390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention