BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 119589 · Received September 12, 1997

    Report

    Report Number
    2027158-1997-00035
    Event Type
    Injury
    Date Received
    September 12, 1997
    Date of Event
    July 7, 1997
    Report Date
    September 8, 1997
    Manufacturer
    THE LARYNGEAL MASK CO.
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GENSIA WAS INFORMED OF A CASE OF PALATAL INJURY AFTER LMA USE. A PHYSICIAN WHO WAS PRESENT DURING THE CASE STATED THAT AFTER THE PT WAS INDUCED, A CRNA INSERTED THE LMA USING THE BACKWARDS/FORWARDS TECHNIQUE. BLEEDING WAS NOTED IMMEDIATELY, AND THE PT WENT INTO LARYNGOSPASM. THE PT WAS INTUBATED, AND AFTER THE AIRWAY WAS UNDER CONTROL AND THE SURGERY WAS UNDERWAY, ENT SURGEONS EXAMINED THE PT AND CAUTERIZED A SOFT PALATE LACERATION. THE PT WAS HOSPITALIZED, BUT IT IS UNK WHETHER THE HOSPITALIZATION WAS INITIATED OR PROLONGED BECAUSE OF THE EVENT. THE PHYSICIAN ATTRIBUTES THE EVENT TO THE INCORRECT INSERTION TECHNIQUE USED BY THE CRNA. THE BACKWARDS/FORWARDS TECHNIQUE IS NOT THE RECOMMENDED INSERTION METHOD, AND THE INSTRUCTION MANUAL CLEARLY STATES, "IT IS IMPORTANT TO FOLLOW THE CORRECT INSERTION TECHNIQUE FOR THE LMA BECAUSE THE DEVICE IS DESIGNED TO BE USED IN A SPECIFIC WAY. ...IT IS POSSIBLE TO TRAUMATIZE THE PT OR OBTAIN AN UNRELIABLE OR OBSTRUCTED AIRWAY IF THE DEVICE IS INSERTED INCORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK CO. STANDARD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention