BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUALIZER PRE-INFLATED AIR WALKER

    MDR report key: 1631206 · Received March 12, 2010

    Report

    Report Number
    1836248-2010-00001
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 18, 2010
    Report Date
    March 12, 2010
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST INCIDENT WE HAVE SEEN OF THIS TYPE OF FAILURE. WE WILL CONTINUE TO MONITOR ALL FAILURES OF THIS PRODUCT LINE AND EXAMINE THIS PRODUCT FOR FURTHER DETAILS.

    Description of Event or Problem · 1

    PATIENT WAS WALKING IN EQUALIZER PRE-INFLATED AIR WALKER WHEN THE STRUT BROKE. THE PATIENT'S DOCTOR INDICATED THAT THE PATIENT WAS NOT INJURED AND MERELY REQUIRED ICING OF THE ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER PRE-INFLATED AIR WALKER ISY OSSUR AMERICAS PW0800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other