BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUALIZER WALKER LOW TOP

    MDR report key: 1668373 · Received April 23, 2010

    Report

    Report Number
    1836248-2010-00003
    Event Type
    Other
    Date Received
    April 23, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 23, 2010
    Manufacturer
    OSSUR AMERICAS
    Product Code
    ITW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) QUALITY ASSURANCE DIRECTOR, SPOKE WITH THE PT ON (B)(6) 2010, TO OBTAIN MORE DETAILS. (B)(4) REVIEWED THE CURRENT DATABASE AND THIS WAS THE FIRST OCCURRENCE FOR THIS ISSUE. HE ASKED HER IF THERE WAS ANYTHING ELSE WE COULD DO AND SHE REPLIED THAT SHE ONLY WANTED TO INFORM US OF THE ISSUE. WE WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    PT CALLED IN TO REPORT INJURY CAUSED BY OUR EQUALIZER LOW TOP WALKER, THE PT STATES THE MEDIAL AND LATERAL STRUTS ARE DIGGING INTO HER SKIN AND THIS HAS CAUSED PRESSURE POINTS. THE PT INDICATED THAT HER DR. STATED PERHAPS HER GATE HAD IMPACTED HER EXPERIENCE WITH THE WALKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUALIZER WALKER LOW TOP ITW OSSUR AMERICAS W0900BLK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other