BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN UNIVERSAL HEAD POSITIONER

    MDR report key: 2794738 · Received October 5, 2012

    Report

    Report Number
    1221538-2012-00014
    Event Type
    Other
    Date Received
    October 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UHP, WHICH WAS SHIPPED BACK FROM (B)(4), WAS ONLY RECEIVED BACK FOR EVALUATION ON (B)(4) 2012. THE ENGINEERING INVESTIGATION IS NOW UNDERWAY. A FOLLOW-UP REPORT WILL BE GENERATED WHEN THE EVALUATION RESULTS ARE COMPLETE.

    Description of Event or Problem · 1

    ON (B)(4) 2012, ALLEN WAS CONTACTED BY OUR DISTRIBUTOR IN (B)(4) REGARDING A BROKEN UNIVERSAL HEAD POSITIONER. ACCORDING TO THE DISTRIBUTOR, THE UHP DEVICE WAS BEING USED IN A PATIENT CASE WHEN IT WAS NOTED THE BASE HAD BECOME BROKEN. ACCORDING TO THE DISTRIBUTOR, THERE WAS NO INJURY TO THE PATIENT AND THERE WAS NOT A SIGNIFICANT IMPACT OR DELAY TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN UNIVERSAL HEAD POSITIONER UHP, HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-90022-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1