BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 8165320 · Received December 14, 2018

    Report

    Report Number
    3008792120-2018-00002
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 14, 2018
    Manufacturer
    SIESTA MEDICAL INC.
    Product Code
    ORY
    PMA / PMN Number
    K133680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT DOES NOT APPEAR THAT THE DEVICE WAS THE DIRECT CAUSE OF THE EVENT AS LARYNGOSPASM IS A RECOGNIZED RISK FROM ANESTHESIA. HOWEVER, THIS EVENT IS BEING REPORTED OUT OF ABUNDANCE OF CAUTION WITH RESPECT TO MDR REQUIREMENTS.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT DURING RECOVERY FROM ANESTHESIA AND AFTER SUCCESSFUL , ROUTINE HYOID SUSPENSION, THE PATIENT EXPERIENCED A LARYNGEAL SPASM. THE PHYSICIAN RETURNED TO THE SURGERY CENTER AT WHICH POINT THE PATIENT WAS NOT BREATHING. THE PHYSICIAN PERFORMED AN EMERGENCY TRACHEOTOMY AND WAS ABLE TO RE-ESTABLISH BREATHING. HOWEVER, THE PATIENT REMAINED IN A COMA. AS OF (B)(6) 2018, THE PHYSICIAN REPORTED THE PATIENT WAS IMPROVING AND WAS RESPONDING TO VERBAL COMMANDS AND CAN MOVE ALL LIMBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005588 ENCORE SYSTEM TONGUE/HYOID SUSPENSION ORY SIESTA MEDICAL INC. FG0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R