BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUALIZER WALKER

    MDR report key: 1639488 · Received March 17, 2010

    Report

    Report Number
    1836248-2010-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    January 28, 2010
    Report Date
    March 16, 2010
    Manufacturer
    OSSUR AMERICAS
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT RECEIVED THIS PRODUCT FROM DR (B)(6) ON (B)(6) 2009. DR (B)(6) PURCHASED THE PRODUCT FROM (B)(4). UPON RECEIPT OF THE PRODUCT AND INSPECTION, IT WAS DETERMINED THAT THIS PRODUCT FAILURE WAS ALREADY ADDRESSED BY A CORRECTIVE ACTION BACK IN JUL 2009. THIS PRODUCT WAS FROM THE LOT PRIOR TO THE CORRECTION. PRODUCTS MANUFACTURED AFTER THE CORRECTIVE ACTION HAVE BEEN INSPECTED AND TRACKED AND WE HAVE NOT SEEN THIS ISSUE ARISE AGAIN.

    Description of Event or Problem · 1

    PT WAS WEARING OUR EQUALIZER WALKER ANKLE BRACE. SHE STOOD UP FROM HER DESK AT WORK, THE LATERAL STRUT BROKE AND THE PT FELL. SHE SAID SHE HAD NO INJURIES OTHER THAN A BRUISED KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER WALKER JWH OSSUR AMERICAS W0800BLK LU090617

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other