BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1194416 · Received October 10, 2008

    Report

    Report Number
    1221538-2008-00008
    Event Type
    Injury
    Date Received
    October 10, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 10, 2008
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S POSITIONING WAS CONDUCTED BY THE ATTENDING STAFF AND DR. THE CASE SURGEON. THE INCIDENT WAS REPORTED DUE TO THE PATIENT OUTCOME. THERE WAS NO REPORT OF A DEVICE DEFECT OR FAILURE. THE DEVICE IN QUESTION IS AN ALLEN MEDICAL FIELD DEMONSTRATION UNIT. IT WAS REVIEWED VISUALLY BY A TRAINED COMPANY REPRESENTATIVE. NO DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    IN 2008, A HEALTHCARE PROFESSIONAL FROM HOSPITA, CONTACTED AN ALLEN SALES REPRESENTATIVE CONCERNING PATIENT COMPLICATIONS FOLLOWING A NINE-HOUR POSITIONING PROCEDURE DURING WHICH THE ALLEN C-FLEX POLAR HEAD POSITIONER WAS USED. THE MALE PATIENT SUSTAINED A PRESSURE INJURY DUE TO POSITIONING ALONG HIS GUMLINE (INSIDE HIS MOUTH). THIS WAS DESCRIBED AS A "BLOOD BLISTER" DUE TO PRESSURE SUSTAINED DURING THE PROLONGED PROCEDURE, ALONG THE GUMLINE. THE PATIENT RECOVERED FROM SOME ADDITIONAL TRANSITORY SYMPTOMS, INCLUDING A RASH NEAR THE MOUTH, AND SOME SHOULDER NUMBNESS. THE PATIENT IS SEEKING POST-OPERATIVE CARE WITH A PERIDONTAL SPECIALIST TO TREAT THE GUMLINE INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Disability