BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 4132020 · Received September 24, 2014

    Report

    Report Number
    3008792120-2014-00008
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    September 22, 2014
    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

    TO DATE, ADDITIONAL ATTEMPTS TO GET MORE INFORMATION FROM THE REPORTING PHYSICIAN HAVE BEEN UNSUCCESSFUL. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE EVENT. ALTHOUGH IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT, THIS MDR IS BEING FILED FOR NOTIFICATION PURPOSES. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PATIENT TREATED WITH TONGUE SUSPENSION HAD DEVELOPED A NECK ABSCESS. THE INFECTION REQUIRED HOSPITALIZATION, ANTI-BACTERIAL IRRIGATION AND SUBSEQUENT REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593583 ENCORE SYSTEM TONGUE/HYOID SUSPENSION SYSTEM ORY SIESTA MEDICAL INC. FG0002 504093A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R