BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANGER

    MDR report key: 2003510 · Received February 18, 2011

    Report

    Report Number
    MW5019503
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    HANGER
    Product Code
    FXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH RIGHT MCA STROKE S/P RIGHT FRONTAL TEMPORO-PARIETAL CRANIECTOMY AND DURAL GRAFT HAD PROTECTIVE HELMET DEVICE DELIVERED AND APPLIED BY ORTHOTIST. APPROX TWO HOURS LATER, PT WAS OBSERVED WITH HELMET SITTING OVER BRIDGE OF THE NOSE WITH PRESSURE AND REDNESS NOTED; ALSO, PRESSURE ON PT'S EAR WITH REDDENED SKIN PRESENT. READJUSTMENT OF HELMET DID NOT RESOLVE PROBLEM AS MOVEMENT WAS RESTRICTED BY HELMET AT THE BACK OF THE PT'S NECK. THE ORTHOTIST WAS CALLED AND CAME TO REASSESS THE DEVICE; PT'S SURGEON WAS ALSO NOTIFIED. THE PT REMAINS INPATIENT AT THE PRESENT TIME WITH RECOMMENDED ADJUSTMENTS/PADDING AS PER ORTHOTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANGER HELMET FXZ HANGER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability