BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 18637001 · Received February 3, 2024

    Report

    Report Number
    1314417-2024-00011
    Event Type
    Injury
    Date Received
    February 3, 2024
    Date of Event
    January 3, 2024
    Report Date
    February 2, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S SMALL ABRASION NOTED ABOVE UVULA AND ABOVE RIGHT TONSIL. THE IMPROPER PLACEMENT OR INTUBATION PROCESS COULD HAVE ALSO BEEN A CAUSE FOR THE PATIENT'S INJURY.

    Additional Manufacturer Narrative · 0

    THE PATIENT'S SMALL ABRASION NOTED ABOVE UVULA AND ABOVE RIGHT TONSIL. THE IMPROPER PLACEMENT OR INTUBATION PROCESS COULD HAVE ALSO BEEN A CAUSE FOR THE PATIENT'S INJURY. THE COMPLAINT OF "FRANK BLOOD NOTED UPON REMOVAL OF AIRQ LMA SIZE 4" REGARDING PART 50405 WAS NOT CONFIRMED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF "DEVICE HAVING SHARP EDGES AND CORNERS AT THE PATIENT END OF THE TRACHEAL TUBE". AN INVENTORY ANALYSIS WAS PERFORMED AND THERE WERE NO NONCONFORMANCES FOUND. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 0

    FRANK BLOOD NOTED UPON REMOVAL OF AIRQ LMA SIZE 4. FRANK BLOOD NOTED UPON REMOVAL OF AIRWAY, WITH SMALL ABRASION NOTED ABOVE UVULA AND ABOVE RIGHT TONSIL.

    Description of Event or Problem · 0

    FRANK BLOOD NOTED UPON REMOVAL OF AIRQ LMA SIZE 4. FRANK BLOOD NOTED UPON REMOVAL OF AIRWAY, WITH SMALL ABRASION NOTED ABOVE UVULA AND ABOVE RIGHT TONSIL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347615 SUNMED LLC AIRQ3 STANDARD ILA WITH MANUAL CUFF INFLATION AND GA SIZE 4.0 CAE SUNMED HOLDINGS LLC 50405 21D2905

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other