BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5084421

    MDR report key: 8374227 · Received February 26, 2019

    Report

    Report Number
    MW5084421
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    February 15, 2019
    Report Date
    February 22, 2019
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE IN PACU AFTER ALMOST 40 MINUTES PATIENT SAT UP AND BEGAN COUGHING THEN SPIT OUT AN APPROX. 1CM PLIABLE ROUND CLEAR PLASTIC CYLINDER. ANESTHESIA AND SURGEONS CALLED TO THE BEDSIDE AND UNABLE TO RECOGNIZE ORIGIN OF PLASTIC PIECE. OPERATING ROOM (OR) CHARGED RN TO THE BEDSIDE AND CALLED STRYKER REP. WHO IDENTIFIED THE PIECE AS THE PROTECTOR ON THE END OF THE MOUTH GUARD/MOUTH RETRACTOR USED INTRAOPERATIVELY. SKLAR INSTRUMENTS (B)(4) US.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other