BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 2860284 · Received November 28, 2012

    Report

    Report Number
    1221538-2012-00017
    Event Type
    Other
    Date Received
    November 28, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ALLEN MEDICAL
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL REPORT WILL BE PREPARED WHEN THE HEAD POSITIONER IS RETURNED AND THE INVESTIGATION COMPLETED.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THEY WOULD BE RETURNING A C-FLEX HEAD POSITIONER FOR REPAIR AFTER A USER NOTED IT WAS "DROOPING" FOLLOWING A PT CASE. THERE WERE NO IMPACTS TO THE CASE AND NO INJURIES TO THE PT, THE DISTRIBUTOR CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX POLAR HEAD POSITIONER C-FLEX, SURGICAL HEAD POSITIONER FWZ ALLEN MEDICAL A-70700-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1