BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 20186469 · Received September 10, 2024

    Report

    Report Number
    3008792120-2024-00009
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 12, 2024
    Report Date
    November 7, 2024
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    FOLLOWING THE PATIENT'S PROCEDURE, WHICH ALSO INCLUDED UPPP AND SEPTOPLASTY, THE PATIENT EXPERIENCED CHOKING ON FOOD, TROUBLE WITH SWALLOWING AIR, DIFFICULTY TALKING, A FEELING OF THE SUTURE PULLING ON THE MANDIBLE, THE DEVICE ANCHORS PROTRUDING, TONSILLAR ARTERY BLEED, AND PAIN.

    Description of Event or Problem · 0

    FOLLOWING THE PATIENT'S PROCEDURE, WHICH ALSO INCLUDED UPPP AND SEPTOPLASTY, THE PATIENT EXPERIENCED CHOKING ON FOOD, TROUBLE WITH SWALLOWING AIR, DIFFICULTY TALKING, A FEELING OF THE SUTURE PULLING ON THE MANDIBLE, THE DEVICE ANCHORS PROTRUDING, TONSILLAR ARTERY BLEED, AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600700 ENCORE SYSTEM INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002 1126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other