BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEM

    MDR report key: 792899 · Received December 8, 2006

    Report

    Report Number
    1221538-2006-00008
    Event Type
    Injury
    Date Received
    December 8, 2006
    Report Date
    December 8, 2006
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE COORDINATOR FOR THE OPERATION SAID THAT DURING THE PROCEDURE, THE PATIENT WAS UNDER GENERAL ANESTHESIA, BUT DID NOT RECEIVE AN ANESTHESIA BLOCK. A TRAINED ALLEN MEDICAL REPRESENTATIVE WAS ON SITE PRIOR TO AND FOLLOWING THE PROCEDURE. THIS REP EVALUATED THE FLEXIFORM VACUUM BLADDER AND HEADREST. NO FUNCTIONAL OR SAFETY ISSUES WERE FOUND. THERE IS NO INDICATION FROM THE USERS THAT THE FLEXIFORM HEADREST EVER FAILED OR MALFUNCTIONED. DESPITE ATTEMPTS TO CONTACT THE CASE SURGEON, HE COULD NOT BE REACHED TO DETERMINE IF FULL PATIENT RECOVERY HAS YET TAKEN PLACE.

    Description of Event or Problem · 1

    A FEMALE PATIENT REPORTED MINOR NUMBNESS IN THE LIPS FOLLOWING A SURGERY IN WHICH THE FLEXIFORM HEADREST WAS USED. THIS DEVICE INCORPORATES A VACUUM BLADDER FILLED WITH POLYMER BEADS THAT CONFORMS TO THE PATIENT'S FACE AND HEAD TO ESTABLISH STABILITY DURING PROCEDURES. AFTER SPEAKING WITH THE PATIENT IN RECOVERY, THE STAFF REPORTED THAT THE PATIENT WAS SLOW TO RECOVER FROM THE NUMBNESS CONDITION IN THE LIP AREA. THE NURSE COORDINATOR REPORTED THAT THE PATIENT WAS DISCHARGED AND THERE WAS NO ADDITIONAL CONTACT WITH THE STAFF AFTER THE INITIAL COMPLAINT WAS ENTERED DURING THE RECOVERY PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEM ALLEN FLEXIFORM HEADREST FWZ ALLEN MEDICAL SYSTEMS A-90017-A4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other