BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 4196000 · Received October 21, 2014

    Report

    Report Number
    3008792120-2014-00010
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 21, 2014
    Manufacturer
    SIESTA MEDICAL INC.
    Product Code
    ORY
    PMA / PMN Number
    K133680
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL, THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE EVENT. ALTHOUGH IT IS UNK 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 ADD'L INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT A PT TREATED WITH TONGUE SUSPENSION HAD DEVELOPED A WOUND INFECTION WHICH WAS TREATED BY IRRIGATION AND WHICH DID NOT RESOLVE. THE PERSISTENT INFECTION LED TO THE REMOVAL OF THE ENCORE IMPLANT (BONE ANCHORS AND SUTURE). INFECTION RESOLUTION WAS REPORTED POST DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669651 ENCORE SYSTEM TONGUE/HYOID SUSPENSION SYSTEM ORY SIESTA MEDICAL INC. FG0002 502044B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UVULOPALATOPHARYNGOPLASTY AND| IMPLANTATION OF THE SIESTA ENCORE DEVICE| TONSILLECTOMY PERFORMED ON THE SAME DATE AS THE