BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LARYNGEAL MASK AIRWAY

    MDR report key: 122332 · Received September 23, 1997

    Report

    Report Number
    2027158-1997-00038
    Event Type
    Injury
    Date Received
    September 23, 1997
    Date of Event
    April 22, 1997
    Report Date
    September 9, 1997
    Manufacturer
    THE LARYNGEAL MASK COMPANY
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    GENSIA'S SAFETY OFFICER REC'D A LETTER FROM A USER FACILITY REGARDING A PT WHO EXPERIENCED A SORE THROAT AND EDEMA TO THE PALATE FOLLOWING THE USE OF AN LMA THAT WAS INAPPROPRIATELY CLEANED WITH A PHENOL AGENT (VESTA-SYDE). THE PT WAS TREATED SUCCESSFULLY BY AN ENT PHYSICIAN ON AN OUTPATIENT BASIS WITH STERIODS, ANTIBIOTICS AND PAIN MEDICATION. THE MFR'S RECOMMENDED CLEANING PROCEDURES WERE DISCUSSED WITH THE FACILITY. SUBSEQUENTLY, THE FACILITY CORRECTED THEIR CLEANING PROCESS AND INSERVICED THEIR STAFF. THE LMA INSTRUCTION MANUAL WARNS AGAINST USING PHENOL CLEANERS AND STATES THAT A SERVERE OR PROLONGED SORE THROAT HAS BEEN REPORTED IN THE PTS IN WHOM AN IMPROPERLY CLEANED OR STERILIZED MASK HAS BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARYNGEAL MASK AIRWAY OROPHARYNGEAL AIRWAY CAE THE LARYNGEAL MASK COMPANY UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention