BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 19983586 · Received August 14, 2024

    Report

    Report Number
    3008792120-2024-00007
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    July 13, 2024
    Report Date
    August 14, 2024
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    UDI-DI
    00862211000206
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT RECEIVED AN IMPLANT ON (B)(6) 2024. THE AREA BECAME INFECTED WITH STREP. INTERMEDIUS AND WAS TREATED WITH ANTIBIOTICS (PO AND IV). THE DEVICE WAS LATER EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552758 ENCORE SYSTEM INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002 1105 00862211000206

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Unknown Required Intervention